Senior Director Data Management (Contract)
About The Position
Jasper is a biotechnology company focused on developing new therapies to treat both chronic and life-threatening diseases. Our mission is to make safer and potentially curative therapy possible for more patients in need. We are bringing together a team of high performing biotech professionals, leading academic institutions and a strong syndicate of healthcare-focused investors to achieve our vision Reporting to the Head of Biometrics Clinical Operations the Data Management Sr.Director plays a critical role in managing the organization, integrity, and analysis of data, which is fundamental for the development of new medical treatments or drugs. As the Data Management Sr.Director at Jasper, you will lead our efforts to manage, secure, and analyze clinical trial data. Your expertise will directly contribute to the advancement of our research and development pipeline, ensuring the highest data quality and integrity standards are met. This role involves strategic planning, team leadership, and close collaboration with cross-functional teams to support our mission of developing groundbreaking medical treatments.
Requirements
- BA/BS or equivalent degree with 12+ years of clinical data management experience in biotechnology or pharmaceutical industry, with outsourced CRO oversight experience.
- Extensive and in-depth knowledge of clinical trial processes, EDC systems, data management principles, and regulatory guidelines (FDA, EMA, etc.), GCP, CDISC, 21CFR Part 11 and ICH guidelines.
- Proven track record of successfully managing data for Phase 1-3 clinical trials. Strong leadership skills with the ability to inspire and motivate a high-performing team.
- Excellent communication, organizational, and problem-solving skills.
- Proficiency in data management software and tools.
Responsibilities
- Develop and implement comprehensive data management strategies that align with clinical trial protocols and regulatory requirements in support of clinical study data milestones and deliverables.
- Zoom in and out while functioning as DM oversight director and DM study lead as needed.
- Ensure the accuracy, completeness, and reliability of clinical trial data through rigorous quality control processes and adherence to industry standards.
- Create, maintain, review and approve key clinical data management deliverables in compliance with FDA and other regulatory bodies, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, user acceptance testing, data entry guidelines, data management plans, data transfer plan, edit check specifications, serious adverse event reconciliation plans, medical coding, data listing specifications, and electronic data transfer agreements.
- Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management CRO and Jasper project team.
- Maintain DM related study documentation and correspondence for (e)TMF.
- Collaborate with biostatisticians and clinical teams to identify data issues and implement resolutions. Ensure timely and accurate reporting of trial data to stakeholders.
- Select and manage external data management vendors, ensuring they meet contractual obligations and maintain high standards of data quality.
- Manages and oversees reconciliation between EDC and non-EDC database, such as, SAE, Lab, and biomarker.
- Develop timelines/milestones for data cleaning, identify data review tasks, and assign and coordinate data review activities to internal and external resources. Ensure deadlines are met and inform key stakeholders of project/program status.
- Serve as the primary point of contact for data management communications with internal teams, external partners, and regulatory agencies.
- Provide clinical data management leadership within the study team(s) to align on and drive data collection requirements for one or more complex clinical development projects.
- Educate clinical team members as needed regarding data management processes, workflow, and data standards that may have direct impact on their work.
- Lead and/or contribute to standardization and process improvement initiatives (e.g. SOP and working procedure development)
- Supervisor, train internal and external data management staff as assigned.
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What This Job Offers
Career Level
Director
