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nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Dec 4th, 2019 12:00AM Clinical Trials Manager (CTM) Open New York NY USA Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases. Abeona is looking for a Clinical Trial Manager to join our team in New York. The successful candidate will be responsible for planning, executing and reporting of a clinical trial(s) according to Abeona standard operating procedures, ICH-GCP and regulatory requirements.  This includes writing and/or reviewing the protocol, informed consent form and other trial documents, Investigator identification and selection, vendor selection and management, data review and trial close-out for one or more phase I-IV global clinical trial.This position is key to good communication and professional relationships with Investigators, site staff, international colleagues in HQs and Affiliates, and CROs. It is the single point of contact within clinical operation for the project team.Major Responsibilities:Responsible for the clinical operation activities from trial start up to close outDrives Investigator identification and selectionDevelopment of trial documentation (e.g. protocol, monitoring plan, manuals, trial document templates)Coordinates preparation of essential documents and IRB/EC/IBC submission packagesEnsure on-time trial start by monitoring the status of or initiating clinical trial supply delivery, provide trial training as needed, and any other activities that support site readiness.Ensures overall completeness of the Abeona Trial Master File to remain inspection ready.Plans and conduct local and global investigator meetings, as needed.Leads clinical trial team meetings. Reports trial status to the project team.Oversees CRO and vendor selection and performance.Serves as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required.Maintains a strong knowledge of the protocol to be able to answer standard questions from CRO, vendors, monitors, and sites.Recognizes potential challenges within the protocol and operational aspects of the trial and resolve or escalate, as appropriate.Responsible for the trial enrolment globally. Assist in setting up contingency plans to ensure enrolment targets are achievedEnsures all operational aspects are on schedule. Oversees clinical trial team activities to achieve trial timelines and quality execution according to Abeona standards and local and international regulations.Oversees CRO and vendor activities and deliverables ensuring quality and rapid issue escalation and resolution as needed.Reviews monitoring visit reports to identify trends/issues. Appropriately escalate issues in a timely manner and ensure resolution. Communicate with monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics.Accountable for coordinating data management activities, ensure timely data entry, data quality and data issue resolution.Reviews data listings (including lab values, screen failures, discontinuations rates), patient profiles, and protocol deviations.Facilitates internal audits and Health Authority inspections as required. Assist in the implementation of corrective actions following audits and inspections.Ensures that all trial close–out activities are performed, in close cooperation with field monitors and clinical trial team/CRO.RequirementsBachelor’s degree in life sciences or healthcare. Master’s degree preferred.3-5+ years of clinical research experience including 2+ years within clinical trial managementRare disease and/or gene therapy experience (preferred)Experience in a role overseeing global clinical studiesAbility to work in a global environment at a fast pace and manage multiple complex projectsSkills & AbilitiesExcellent analytical, verbal, and written communication skills.Strong organizational and time management skills.Quality oriented with attention to details.Highly proactive, self-motivated, professional and dedicated.Demonstrated computer skills (MS Office, MS Project, EDC, IXRS, eTMF, and CTMS preferred).Ability to drive and willingness to travel for study related meetings, monitoring and auditing visits, as needed. Dec 3rd, 2019 09:04PM Dec 3rd, 2019 09:04PM
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Dec 4th, 2019 12:00AM Director of Data Management -- Clinical Operations Open Clinical Operations New York NY USA Director of Data Management is accountable for all operational and strategic aspects of Data Management supporting product development activities and clinical decision-making. The candidate will be responsible for all aspects of data management for development, implementation and timely completion of clinical trials while maintaining a high level of data quality by adhering to corporate, industry and regulatory agency standards.ResponsibilitiesManage data management resources and budget, biometrics vendors and CRO activitiesProvide strategic and tactical data management input for clinical trial design and analysis, including participation in protocol development processParticipate in the writing, review, and finalization of regulatory documents, CSRs, abstracts, and manuscripts for publicationLead the development and adaptation of new data management platforms and in support of drug development, keeping current with regulatory guidance and requirements in the global environment to meet project objectives and regulatory data and statistical requirementsAssess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concernsKey Deliverables:Management of biometrics vendor and CRO activities, including development of CRFs, edit check specifications, SAS dataset specifications, data management plans, SAP, TFLs, review of clinical data, user acceptance testing for EDC systems and reporting data trends and query metricsDevelopment and implementation of CDISC-compliant data standardsDevelopment and adaptation of new data management platforms in support of drug development; keeping current with regulatory guidance and requirements in the global environment; ensure integrity of all clinical trial data; provide statistically sound scientific methodology input to meet project objectives and regulatory data and statistical requirementsManage biometrics & data management resources and budget. Supervise internal and/or contract programmers and data managers, and oversee/manage biometrics vendorsProvide biometrics representation and leadership in clinical trial design and analysis, including participation in protocol development process with responsibility for biometrics-related sections of the protocol.  Responsible for reviewing the Statistical Analysis Plan (SAP), including the resulting tables, figures, and listings for inclusion in the clinical study report (CSR) and/or publicationRequirements:Master's degree in sciences or other closely related discipline with 15+ years of prior data management in a drug-development environment or in the pharmaceutical/biotech industryStatistical knowledge and experience a strong plus.Track record of leading and managing and Data Management functions, leverage internal and external resources, and experience in timeline/resource/budget planning and vendor/contractor oversightExperience with both in-house and outsourced Biometrics modelsIn-depth knowledge of the global drug development process; hands-on experience with clinical trials (Phase I to IV)Extensive knowledge of data management methodologies used in clinical trialsExperience with NDA, BLA, and/or MAA submission and related late-stage approval activitiesKnowledge of regulatory guidelines, including GCP, FDA/EMA/CHMP and ICH guidelinesExperience working with and managing external biometrics vendors (CROs, etc.)Extensive experience with all aspects of DM activities in clinical trials including: development of CRFs, edit check specifications, SAS dataset specifications, data management plans and timelines; management of vendor and CRO activitiesEvaluation, selection and implementation of various EDC and IWRS platforms; programming edit checks and data listings using SAS; custom reporting applications and medical coding software; creating specifications for database design and validation programs; eCRF design and buildImplementation of CDISC data standards across multiple clinical studies (CDASH, SDTM, ADaM)Strong management skills, and ability to effectively lead and collaborate with various business functionsHigh attention to detail including proven ability to manage multiple, competing prioritiesExcellent operational leadership skills, including collaboration and influence with key stakeholders and senior leadershipStrong communication, project management and problem-solving skills, focus on collaboration, adaptability, adherence to compliance, and ability to enhance processes and ensure quality through innovative solutionsAbility to motivate and inspire people to share the visionCourage to challenge stakeholders as well as team members for the best resultsAbility to think outside the box and challenge status quoPassion for InnovationFlexible to ever-changing priorities internally and externallyAdaptable to objectives shifting during the projectHands-on involvementAbility to translate a vision into actionable work streams Dec 3rd, 2019 09:04PM Dec 3rd, 2019 09:04PM
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Dec 4th, 2019 12:00AM Clinical Trials Manager (CTM) Open Cleveland OH USA Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases.  Abeona is looking for a Clinical Trial Manager to join our team in Cleveland, OH. The successful candidate will be responsible for planning, executing and reporting of a clinical trial(s) according to Abeona standard operating procedures, ICH-GCP and regulatory requirements.  This includes writing and/or reviewing the protocol, informed consent form and other trial documents, Investigator identification and selection, vendor selection and management, data review and trial close-out for one or more phase I-IV global clinical trial. This position is key to good communication and professional relationships with Investigators, site staff, international colleagues in HQs and Affiliates, and CROs. It is the single point of contact within clinical operation for the project team. Major Responsibilities: Responsible for the clinical operation activities from trial start up to close out Drives Investigator identification and selection Development of trial documentation (e.g. protocol, monitoring plan, manuals, trial document templates) Coordinates preparation of essential documents and IRB/EC/IBC submission packages Ensure on-time trial start by monitoring the status of or initiating clinical trial supply delivery, provide trial training as needed, and any other activities that support site readiness. Ensures overall completeness of the Abeona Trial Master File to remain inspection ready. Plans and conduct local and global investigator meetings, as needed. Leads clinical trial team meetings. Reports trial status to the project team. Oversees CRO and vendor selection and performance. Serves as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required. Maintains a strong knowledge of the protocol to be able to answer standard questions from CRO, vendors, monitors, and sites. Recognizes potential challenges within the protocol and operational aspects of the trial and resolve or escalate, as appropriate. Responsible for the trial enrolment globally. Assist in setting up contingency plans to ensure enrolment targets are achieved Ensures all operational aspects are on schedule. Oversees clinical trial team activities to achieve trial timelines and quality execution according to Abeona standards and local and international regulations. Oversees CRO and vendor activities and deliverables ensuring quality and rapid issue escalation and resolution as needed. Reviews monitoring visit reports to identify trends/issues. Appropriately escalate issues in a timely manner and ensure resolution. Communicate with monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics. Accountable for coordinating data management activities, ensure timely data entry, data quality and data issue resolution. Reviews data listings (including lab values, screen failures, discontinuations rates), patient profiles, and protocol deviations. Facilitates internal audits and Health Authority inspections as required. Assist in the implementation of corrective actions following audits and inspections. Ensures that all trial close–out activities are performed, in close cooperation with field monitors and clinical trial team/CRO. Requirements Bachelor’s degree in life sciences or healthcare. Master’s degree preferred. 3-5+ years of clinical research experience including 2+ years within clinical trial management Rare disease and/or gene therapy experience (preferred) Experience in a role overseeing global clinical studies Ability to work in a global environment at a fast pace and manage multiple complex projects Skills & Abilities Excellent analytical, verbal, and written communication skills. Strong organizational and time management skills. Quality oriented with attention to details. Highly proactive, self-motivated, professional and dedicated. Demonstrated computer skills (MS Office, MS Project, EDC, IXRS, eTMF, and CTMS preferred). Ability to drive and willingness to travel for study related meetings, monitoring and auditing visits, as needed. Dec 3rd, 2019 09:04PM Dec 3rd, 2019 09:04PM
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Dec 4th, 2019 12:00AM Director of Data Management -- Clinical Operations Open Clinical Operations Cleveland OH USA Director of Data Management is accountable for all operational and strategic aspects of Data Management supporting product development activities and clinical decision-making. The candidate will be responsible for all aspects of data management for development, implementation and timely completion of clinical trials while maintaining a high level of data quality by adhering to corporate, industry and regulatory agency standards.ResponsibilitiesManage data management resources and budget, biometrics vendors and CRO activitiesProvide strategic and tactical data management input for clinical trial design and analysis, including participation in protocol development processParticipate in the writing, review, and finalization of regulatory documents, CSRs, abstracts, and manuscripts for publicationLead the development and adaptation of new data management platforms and in support of drug development, keeping current with regulatory guidance and requirements in the global environment to meet project objectives and regulatory data and statistical requirementsAssess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concernsKey Deliverables:Management of biometrics vendor and CRO activities, including development of CRFs, edit check specifications, SAS dataset specifications, data management plans, SAP, TFLs, review of clinical data, user acceptance testing for EDC systems and reporting data trends and query metricsDevelopment and implementation of CDISC-compliant data standardsDevelopment and adaptation of new data management platforms in support of drug development; keeping current with regulatory guidance and requirements in the global environment; ensure integrity of all clinical trial data; provide statistically sound scientific methodology input to meet project objectives and regulatory data and statistical requirementsManage biometrics & data management resources and budget. Supervise internal and/or contract programmers and data managers, and oversee/manage biometrics vendorsProvide biometrics representation and leadership in clinical trial design and analysis, including participation in protocol development process with responsibility for biometrics-related sections of the protocol.  Responsible for reviewing the Statistical Analysis Plan (SAP), including the resulting tables, figures, and listings for inclusion in the clinical study report (CSR) and/or publicationRequirements:Master's degree in sciences or other closely related discipline with 15+ years of prior data management in a drug-development environment or in the pharmaceutical/biotech industryStatistical knowledge and experience a strong plus.Track record of leading and managing and Data Management functions, leverage internal and external resources, and experience in timeline/resource/budget planning and vendor/contractor oversightExperience with both in-house and outsourced Biometrics modelsIn-depth knowledge of the global drug development process; hands-on experience with clinical trials (Phase I to IV)Extensive knowledge of data management methodologies used in clinical trialsExperience with NDA, BLA, and/or MAA submission and related late-stage approval activitiesKnowledge of regulatory guidelines, including GCP, FDA/EMA/CHMP and ICH guidelinesExperience working with and managing external biometrics vendors (CROs, etc.)Extensive experience with all aspects of DM activities in clinical trials including: development of CRFs, edit check specifications, SAS dataset specifications, data management plans and timelines; management of vendor and CRO activitiesEvaluation, selection and implementation of various EDC and IWRS platforms; programming edit checks and data listings using SAS; custom reporting applications and medical coding software; creating specifications for database design and validation programs; eCRF design and buildImplementation of CDISC data standards across multiple clinical studies (CDASH, SDTM, ADaM)Strong management skills, and ability to effectively lead and collaborate with various business functionsHigh attention to detail including proven ability to manage multiple, competing prioritiesExcellent operational leadership skills, including collaboration and influence with key stakeholders and senior leadershipStrong communication, project management and problem-solving skills, focus on collaboration, adaptability, adherence to compliance, and ability to enhance processes and ensure quality through innovative solutionsAbility to motivate and inspire people to share the visionCourage to challenge stakeholders as well as team members for the best resultsAbility to think outside the box and challenge status quoPassion for InnovationFlexible to ever-changing priorities internally and externallyAdaptable to objectives shifting during the projectHands-on involvementAbility to translate a vision into actionable work streams Dec 3rd, 2019 09:04PM Dec 3rd, 2019 09:04PM
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Dec 4th, 2019 12:00AM Scientist, Process Development Open Process Development Cleveland OH USA Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases. Abeona is looking for a Scientist, Process Development, to join our team in Cleveland, OH. The successful candidate will be responsible conducting Process Development for clinical and/or commercial purposes in diverse biological areas and for a variety of products. Skilled in leading process development, its principles and practices. Relies on experience and judgment to plan, execute and accomplish goals and can coordinate with peers in other disciplines (AD, QC, Mfg, QA, Reg, etc.) for project planning and coordinated execution.Essential Duties and ResponsibilitiesInitiates, plans, and executes all aspects of project leadership and project management in more than one development study for new processes or key process improvements (includes protocol and report writing; laboratory skills training and SOP documentation needs, etc.)Identifies and evaluates new scientific approaches or methods to improve the products/processes of AbeonaServes as an internal Subject Matter Expert (SME), advises management on process/product issuesProvides leadership and input with others on multidisciplinary teams for planning, implementation, analyses and problem solvingLead CMC contributor in SME areasRepresents the company at external manufacturing/scientific conferencesQualificationsBachelor’s degree in science and 7 or more years relevant experience, orMasters degree in science and 5 or more years relevant experience, orPhD in science with 2 to 5 years relevant experienceOther Skills and AbilitiesDemonstrates ability to lead and teach Process Development Associates and perform technology transfers as appropriate.  Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 30 pounds is required. Dec 3rd, 2019 09:04PM Dec 3rd, 2019 09:04PM
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Dec 4th, 2019 12:00AM Senior Scientist, Process Development Open Process Development Cleveland OH USA Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases. Abeona is looking for a Senior Scientist, Process Development, to join our team in Cleveland, OH. The successful candidate will be responsible conducting Process Development for clinical and/or commercial purposes in diverse biological areas and for a variety of products. Skilled in leading process development, its principles and practices. Relies on extensive experience and judgment to plan, budget, execute and accomplish goals and can coordinate with leaders in other disciplines (AD, QC, Mfg, QA, Reg, etc.) for comprehensive project planning and coordinated execution.Essential Duties and ResponsibilitiesInitiates, plans, and executes all aspects of project leadership and project management in multiple development studies for new processes or key process improvements (includes protocol and report writing; laboratory skills training and SOP documentation needs, etc.)Identifies and evaluates new scientific approaches or methods to improve the products/processes of AbeonaServes as an internal Subject Matter Expert (SME), advises management on process/product issuesProvides leadership and input with others on multidisciplinary teams for planning, implementation, analyses and problem solvingLead CMC contributor in SME areasRepresents the company at external manufacturing/scientific conferencesQualificationsBachelor’s degree in science and 10 or more years relevant experience, orMaster’s degree in science and 7 or more years relevant experience, orPhD in science with 4 to 7 years relevant experienceOther Skills and AbilitiesDemonstrates ability to lead and teach Process Development Associates and Scientists and perform technology transfers as appropriate.  Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 30 pounds is required. Dec 3rd, 2019 09:04PM Dec 3rd, 2019 09:04PM
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Dec 4th, 2019 12:00AM AAV Process Development Associate Open Process Development Cleveland OH USA Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases. Abeona is looking for an AAV Process Development Associate to join our team in Cleveland, OH. The successful candidate will be responsible for the weekly screening and lab scale expression and purification of novel AAV vector candidates provided by R& D which is critical to support our clinical Gene Therapy programs in neurological, lysosomal storage disorders, and other gene therapy indications.Responsibilities:Support the vector needs of the R&D team with small scale production and purification of AAV vectorsMaintain impeccable records from raw data including lab notebooks, log books and computer generated data filesPrecisely follow laboratory protocols and adhere to work training – safety, process, quality. Note any exceptions or deviations when working with novel vector constructs regarding expression, purification or growth trends.Accurately interpret experimental data, perform statistical analysis, formulate conclusions and communicate data with Process Development colleagues and cross-functional teamsDevelop new small scale processes as appropriateServe on departmental and inter-departmental teamsAssist in regular lab management tasks such as inventory control, ordering, cleaning, waste disposal, calibration and equipment maintenance.Qualifications:BS or equivalent in scientific discipline and min of 0-2 years related lab experience – an Associate’s degree with relevant experience may be acceptableGeneral biological lab experienceExperience with mammalian and/or insect cell culture technology (i.e. aseptic technique) Experience with the purification of proteins or viruses or viral vectorsExperience with analytical methods such as kinetic or binding assays (ex. ELISA) and cell-based functional assaysGLP experienceWork within a team structure and on individual projectsExcellent oral and written communication skillsDemonstration of detailed record keeping and data documentationStrong inter-personnel skills Dec 3rd, 2019 09:04PM Dec 3rd, 2019 09:04PM
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Dec 5th, 2019 12:00AM Clinical Trials Manager (CTM) Open New York NY USA Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases. Abeona is looking for a Clinical Trial Manager to join our team in New York. The successful candidate will be responsible for planning, executing and reporting of a clinical trial(s) according to Abeona standard operating procedures, ICH-GCP and regulatory requirements.  This includes writing and/or reviewing the protocol, informed consent form and other trial documents, Investigator identification and selection, vendor selection and management, data review and trial close-out for one or more phase I-IV global clinical trial.This position is key to good communication and professional relationships with Investigators, site staff, international colleagues in HQs and Affiliates, and CROs. It is the single point of contact within clinical operation for the project team.Major Responsibilities:Responsible for the clinical operation activities from trial start up to close outDrives Investigator identification and selectionDevelopment of trial documentation (e.g. protocol, monitoring plan, manuals, trial document templates)Coordinates preparation of essential documents and IRB/EC/IBC submission packagesEnsure on-time trial start by monitoring the status of or initiating clinical trial supply delivery, provide trial training as needed, and any other activities that support site readiness.Ensures overall completeness of the Abeona Trial Master File to remain inspection ready.Plans and conduct local and global investigator meetings, as needed.Leads clinical trial team meetings. Reports trial status to the project team.Oversees CRO and vendor selection and performance.Serves as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required.Maintains a strong knowledge of the protocol to be able to answer standard questions from CRO, vendors, monitors, and sites.Recognizes potential challenges within the protocol and operational aspects of the trial and resolve or escalate, as appropriate.Responsible for the trial enrolment globally. Assist in setting up contingency plans to ensure enrolment targets are achievedEnsures all operational aspects are on schedule. Oversees clinical trial team activities to achieve trial timelines and quality execution according to Abeona standards and local and international regulations.Oversees CRO and vendor activities and deliverables ensuring quality and rapid issue escalation and resolution as needed.Reviews monitoring visit reports to identify trends/issues. Appropriately escalate issues in a timely manner and ensure resolution. Communicate with monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics.Accountable for coordinating data management activities, ensure timely data entry, data quality and data issue resolution.Reviews data listings (including lab values, screen failures, discontinuations rates), patient profiles, and protocol deviations.Facilitates internal audits and Health Authority inspections as required. Assist in the implementation of corrective actions following audits and inspections.Ensures that all trial close–out activities are performed, in close cooperation with field monitors and clinical trial team/CRO.RequirementsBachelor’s degree in life sciences or healthcare. Master’s degree preferred.3-5+ years of clinical research experience including 2+ years within clinical trial managementRare disease and/or gene therapy experience (preferred)Experience in a role overseeing global clinical studiesAbility to work in a global environment at a fast pace and manage multiple complex projectsSkills & AbilitiesExcellent analytical, verbal, and written communication skills.Strong organizational and time management skills.Quality oriented with attention to details.Highly proactive, self-motivated, professional and dedicated.Demonstrated computer skills (MS Office, MS Project, EDC, IXRS, eTMF, and CTMS preferred).Ability to drive and willingness to travel for study related meetings, monitoring and auditing visits, as needed. Dec 4th, 2019 09:04PM Dec 4th, 2019 09:04PM
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Dec 5th, 2019 12:00AM Director of Data Management -- Clinical Operations Open Clinical Operations New York NY USA Director of Data Management is accountable for all operational and strategic aspects of Data Management supporting product development activities and clinical decision-making. The candidate will be responsible for all aspects of data management for development, implementation and timely completion of clinical trials while maintaining a high level of data quality by adhering to corporate, industry and regulatory agency standards.ResponsibilitiesManage data management resources and budget, biometrics vendors and CRO activitiesProvide strategic and tactical data management input for clinical trial design and analysis, including participation in protocol development processParticipate in the writing, review, and finalization of regulatory documents, CSRs, abstracts, and manuscripts for publicationLead the development and adaptation of new data management platforms and in support of drug development, keeping current with regulatory guidance and requirements in the global environment to meet project objectives and regulatory data and statistical requirementsAssess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concernsKey Deliverables:Management of biometrics vendor and CRO activities, including development of CRFs, edit check specifications, SAS dataset specifications, data management plans, SAP, TFLs, review of clinical data, user acceptance testing for EDC systems and reporting data trends and query metricsDevelopment and implementation of CDISC-compliant data standardsDevelopment and adaptation of new data management platforms in support of drug development; keeping current with regulatory guidance and requirements in the global environment; ensure integrity of all clinical trial data; provide statistically sound scientific methodology input to meet project objectives and regulatory data and statistical requirementsManage biometrics & data management resources and budget. Supervise internal and/or contract programmers and data managers, and oversee/manage biometrics vendorsProvide biometrics representation and leadership in clinical trial design and analysis, including participation in protocol development process with responsibility for biometrics-related sections of the protocol.  Responsible for reviewing the Statistical Analysis Plan (SAP), including the resulting tables, figures, and listings for inclusion in the clinical study report (CSR) and/or publicationRequirements:Master's degree in sciences or other closely related discipline with 15+ years of prior data management in a drug-development environment or in the pharmaceutical/biotech industryStatistical knowledge and experience a strong plus.Track record of leading and managing and Data Management functions, leverage internal and external resources, and experience in timeline/resource/budget planning and vendor/contractor oversightExperience with both in-house and outsourced Biometrics modelsIn-depth knowledge of the global drug development process; hands-on experience with clinical trials (Phase I to IV)Extensive knowledge of data management methodologies used in clinical trialsExperience with NDA, BLA, and/or MAA submission and related late-stage approval activitiesKnowledge of regulatory guidelines, including GCP, FDA/EMA/CHMP and ICH guidelinesExperience working with and managing external biometrics vendors (CROs, etc.)Extensive experience with all aspects of DM activities in clinical trials including: development of CRFs, edit check specifications, SAS dataset specifications, data management plans and timelines; management of vendor and CRO activitiesEvaluation, selection and implementation of various EDC and IWRS platforms; programming edit checks and data listings using SAS; custom reporting applications and medical coding software; creating specifications for database design and validation programs; eCRF design and buildImplementation of CDISC data standards across multiple clinical studies (CDASH, SDTM, ADaM)Strong management skills, and ability to effectively lead and collaborate with various business functionsHigh attention to detail including proven ability to manage multiple, competing prioritiesExcellent operational leadership skills, including collaboration and influence with key stakeholders and senior leadershipStrong communication, project management and problem-solving skills, focus on collaboration, adaptability, adherence to compliance, and ability to enhance processes and ensure quality through innovative solutionsAbility to motivate and inspire people to share the visionCourage to challenge stakeholders as well as team members for the best resultsAbility to think outside the box and challenge status quoPassion for InnovationFlexible to ever-changing priorities internally and externallyAdaptable to objectives shifting during the projectHands-on involvementAbility to translate a vision into actionable work streams Dec 4th, 2019 09:04PM Dec 4th, 2019 09:04PM
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Dec 5th, 2019 12:00AM Clinical Trials Manager (CTM) Open Cleveland OH USA Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases.  Abeona is looking for a Clinical Trial Manager to join our team in Cleveland, OH. The successful candidate will be responsible for planning, executing and reporting of a clinical trial(s) according to Abeona standard operating procedures, ICH-GCP and regulatory requirements.  This includes writing and/or reviewing the protocol, informed consent form and other trial documents, Investigator identification and selection, vendor selection and management, data review and trial close-out for one or more phase I-IV global clinical trial. This position is key to good communication and professional relationships with Investigators, site staff, international colleagues in HQs and Affiliates, and CROs. It is the single point of contact within clinical operation for the project team. Major Responsibilities: Responsible for the clinical operation activities from trial start up to close out Drives Investigator identification and selection Development of trial documentation (e.g. protocol, monitoring plan, manuals, trial document templates) Coordinates preparation of essential documents and IRB/EC/IBC submission packages Ensure on-time trial start by monitoring the status of or initiating clinical trial supply delivery, provide trial training as needed, and any other activities that support site readiness. Ensures overall completeness of the Abeona Trial Master File to remain inspection ready. Plans and conduct local and global investigator meetings, as needed. Leads clinical trial team meetings. Reports trial status to the project team. Oversees CRO and vendor selection and performance. Serves as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required. Maintains a strong knowledge of the protocol to be able to answer standard questions from CRO, vendors, monitors, and sites. Recognizes potential challenges within the protocol and operational aspects of the trial and resolve or escalate, as appropriate. Responsible for the trial enrolment globally. Assist in setting up contingency plans to ensure enrolment targets are achieved Ensures all operational aspects are on schedule. Oversees clinical trial team activities to achieve trial timelines and quality execution according to Abeona standards and local and international regulations. Oversees CRO and vendor activities and deliverables ensuring quality and rapid issue escalation and resolution as needed. Reviews monitoring visit reports to identify trends/issues. Appropriately escalate issues in a timely manner and ensure resolution. Communicate with monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics. Accountable for coordinating data management activities, ensure timely data entry, data quality and data issue resolution. Reviews data listings (including lab values, screen failures, discontinuations rates), patient profiles, and protocol deviations. Facilitates internal audits and Health Authority inspections as required. Assist in the implementation of corrective actions following audits and inspections. Ensures that all trial close–out activities are performed, in close cooperation with field monitors and clinical trial team/CRO. Requirements Bachelor’s degree in life sciences or healthcare. Master’s degree preferred. 3-5+ years of clinical research experience including 2+ years within clinical trial management Rare disease and/or gene therapy experience (preferred) Experience in a role overseeing global clinical studies Ability to work in a global environment at a fast pace and manage multiple complex projects Skills & Abilities Excellent analytical, verbal, and written communication skills. Strong organizational and time management skills. Quality oriented with attention to details. Highly proactive, self-motivated, professional and dedicated. Demonstrated computer skills (MS Office, MS Project, EDC, IXRS, eTMF, and CTMS preferred). Ability to drive and willingness to travel for study related meetings, monitoring and auditing visits, as needed. Dec 4th, 2019 09:04PM Dec 4th, 2019 09:04PM

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