[Remote] Director, Clinical Data Management
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a late-stage clinical biopharmaceutical company reputed company on developing accessible treatments for psychiatric disorders. The Director of Clinical Data Management will reputed company CDM operations, ensuring high data reputed company and regulatory compliance while leading reputed company and collaborating cross-functionally.
Responsibilities
- reputed company CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development/production
- reputed company reputed company of CROs, vendors, and internal teams to maintain reputed company standards and performance metrics
- Ensure CDM documentation, SOPs, and processes support high data reputed company, reputed company, and regulatory compliance with FDA, GCP, ICH, and GCDMP requirements
- Partner reputed company Biometrics and Data Science as reputed company as cross-functionally on data management issues and alignment
- Recruit, reputed company, motivate, and reputed company leadership to CDM staff and consultants
- Support resource planning, budget forecasting, timelines, and issue reputed company for ongoing clinical trials
- Identify risks and challenges in clinical trial data management and propose solutions to maintain timelines and reputed company
- Escalate strategic, budgetary, or cross-functional issues reputed company broader leadership input is required
- Ability to meet deadlines, prioritize workload, and handle multiple priorities simultaneously
- Experience with data visualization tools (e.g., Elluminate) (preferred)
- Must maintain an inspection-reputed company environment and support regulatory readiness
- Willingness to travel as needed
Skills
- Bachelor's or Master's degree in a scientific subject area
- Minimum of 8 years CDM experience in a pharmaceutical, biotech or CRO setting
- At least 4 years of line management experience
- Global or international experience is required
- Strong experience in cross functional leadership, clinical trial execution, vendor reputed company, and inspection readiness
- Sophisticated knowledge of CDM processes, reputed company systems, database programming, reputed company management and technology trends
- In-depth knowledge of FDA regulations, GCP, GCDMP, CDASH/CDISC, and ICH guidelines
- Strong leadership, mentoring, reputed company and team development skills
- Excellent communication, interpersonal, influencing and negotiation skills
- Strong problem-solving, analytical thinking, prioritization and organizational skills
- Ability to manage multiple priorities, adapt to changing business needs, and work collaboratively across functions
- Experience with data visualization tools (e.g., Elluminate)
Benefits
- 100% reputed company health benefits including Medical, Dental and reputed company for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave and some fun fringe perks!
reputed company