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4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery
GENERAL SUMMARY:
The AD, Data Management will be responsible for performing or overseeing vendors to perform Data Management operational end-to-end activities and participate as an active member in a cross-function study team to plan, lead, and execute tasks required for assigned clinical studies across all phases. The AD, Data Management has a broad, fundamental knowledge of the data management process and can perform most required tasks with minimal guidance.
Data management is one of the essential functions of the Clinical Development organization at 4DMT. Together with the other two functions within the Data Science group, Biostatistics, and Statistical Programming, we provide critical support for the company’s clinical development programs in gene therapies for retina diseases and other therapeutic areas.
MAJOR DUTIES & RESPONSIBILITIES:
- Lead Data Management of a clinical study or a series of related studies with minimal guidance
- Manage and monitor the progress of data management activities with CROs, vendors, and stats/programming 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 Electronic Data Capture (EDC) system design and testing according to company standards.
- Develop or lead the development of the Data Management and Data Transfer Plan for assigned clinical studies.
- Attend study meetings and provide Data Management updates and metrics.
- 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 or ensure assigned CRO 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 data management files / eTMF
- Perform and coordinate database interim snapshot, lock, and freeze activities
- Other duties as assigned: nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time
QUALIFICATIONS:
Education:
- B.A./B.S. degree or higher (life-science-related fields preferred); or equivalent experience.
Experience:
- 9+ years of data management experience in the biotech/pharmaceutical industry or clinical data management service providers of which at least three (3+) years in a lead study data manager role.
- Experience in retina diseases and/or gene therapies a plus.
- Hands-on operational experience as Data Management Lead in all phases of clinical trials, including development/deployment/validation/maintenance/closeout of a clinical database, coordination of data transfers/reconciliations, training on data management systems, etc.
- Experience in vendor management and performance assessments
- In-depth knowledge and experience with CDISC data standards and models.
Other Qualifications/Skills:
- Proficient in using clinical data management systems (e.g., Medidata Rave) and the data flow, including those from external sources (IRT, safety, central/specialty labs, reading centers, PROs, etc.)
- Proficiency in data management process and knowledge of Good Clinical Data Management Practices (GCDMP) in global clinical trials
- Knowledge of ICH GCP and other applicable regulatory rules and guidelines.
- Knowledge of the clinical development process.
- Proficient with MS Office (Worl, Excel, PowerPoint, etc.)
- Excellent interpersonal communication skills (written and verbal)
- Innate collaborative attitude, with demonstrated ability to work effectively in a small company environment that moves at a tremendous pace.
- Excellent organization and project/time management skills
- Ability to multitask in a high-volume environment with shifting priority and conflicting deadlines
- Proven conceptual, analytical and strategic thinking
- Excellent attention to details
Travel: 5%
Physical Requirements and Working Conditions:
- Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Base salary compensation range: $170,000/yr - $223,000/yr
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.
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