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Director, Clinical Data Management

1 week, 4 days ago
Anywhere
Full-time
Lead
Program Manager
Database Administration
GCP
Apply Now
Definium Therapeutics

Definium Therapeutics

Definium Therapeutics is dedicated to advancing psychiatry by developing accessible treatments that leverage the therapeutic potential of psychedelic medicine, guided by scientific rigor and a commitment to addressing the root causes of mental health i...

Health Care Providers & Services
51-250
Founded 2019
View All Jobs 19

Description

  • Oversee clinical data management operations, including CRF/eCRF design, validation programming, discrepancy management, and database development and production.
  • Provide oversight of CROs, vendors, and internal teams to maintain quality standards and performance metrics.
  • Ensure documentation, SOPs, and processes support high data quality, data integrity, and regulatory compliance.
  • Partner with Biometrics, Data Science, and cross-functional teams to align on data management issues.
  • Recruit, develop, motivate, and lead CDM staff and consultants.
  • Support resource planning, budget forecasting, timelines, and issue resolution for ongoing clinical trials.
  • Identify risks and challenges in clinical trial data management and propose solutions to maintain timelines and quality.
  • Escalate strategic, budgetary, or cross-functional issues when broader leadership input is needed.
  • Maintain an inspection-ready environment and support regulatory readiness.
  • Travel as needed.

Requirements

  • Bachelor’s or Master’s degree in a scientific subject area.
  • Minimum of 8 years of 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 oversight, and inspection readiness.
  • Sophisticated knowledge of CDM processes, EDC systems, database programming, quality management, and technology trends.
  • In-depth knowledge of FDA regulations, GCP, GCDMP, CDASH/CDISC, and ICH guidelines.
  • Strong leadership, mentoring, recruiting, 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 such as Elluminate is preferred.

Benefits

  • Starting base pay range of $208,400.00 to $234,737.00.
  • Additional compensation may include bonus and equity.
  • 100% paid health benefits, including medical, dental, and vision for employees and dependents.
  • 401(k) program with company match and vesting after the first month.
  • Flexible time off.
  • Generous parental leave.
  • Access to additional fringe perks.

Interested in this position?

Apply directly on the company website

Apply Now

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