Sr. Data Manager (Contract)
4D Molecular Therapeutics, Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused in three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently conducting three clinical trials: 4D-125 is in a Phase 1/2 clinical trial for XLRP, 4D-110 is in a Phase 1 clinical trial for choroideremia and 4D-310 is in a Phase 1/2 clinical trial for Fabry disease.
4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers competitive salary and benefits, and provides challenging opportunities for career development. 4D Molecular Therapeutics is located in Emeryville, CA.
The Consultant Senior Data Manager will be responsible for performing Data Management activities that support observational clinical programs worldwide. They will participate as an active member of a cross-functional study team to plan, lead and execute the Data Management tasks required for all phase 1-4 studies. The Consultant Senior Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance.
- Lead Data Management of a clinical study or a series of related studies with minimal guidance
- Provide leadership to lower level Data Management staff assigned to his/her studies
- Manage and monitor the progress of data management activities with CROs, vendors and stats/programing groups on assigned studies
- Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
- Perform a thoroughly detailed review of eCRF data requirements.
- Lead the development of data edit check specifications and data listings
- Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards.
- Develop or lead the development of the Data Management and Data Transfer Plan for a clinical study.
- Review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical Analysis Plans and vendor specifications
- Provide training on the EDC system and/or eCRF Completion Guidelines to internal and external study team members as needed
- Perform reconciliation of header data from external data sources against the clinical database
- Perform or ensure assigned CRO completed Serious Adverse Event reconciliation activities according to SOPs and guidelines
- Lead database upgrades/migrations including performing User Acceptance Testing
- Maintain study workbooks and data management files
- Perform and coordinate database lock and freeze activities per company SOPs
- BA/BS degree or higher, preferably in medical or biological sciences
- Minimum of 6 years of CDM experience in the pharmaceutical industry.
- Minimum 2 years of managerial experience.
- Excellent written and verbal communication skills and collaborative working style.
- Proven conceptual, analytical and strategic thinking.
- Experience standardizing CDM & data flow processes.
- Demonstrated project management skills.
- Proactively identifies risks, issues, and possible solutions.
- Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities and/or conflicting deadlines.
- Ability to build a rapport and trust with others through leadership and dependability.
- Extensive knowledge of Clinical Systems (e.g. EDC, IXRS) and external data vendors (e.g. Central Laboratories).
- Knowledge of GCP/FDA/ICH regulations required.
- Physical Requirements:
- Adhere to 4DMT COVID protocols and policy
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran and any other category protected under applicable federal, state, provincial and local laws.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities