Director, Clinical Data Management

Role Summary

Director of Clinical Data Management. Responsible for all data processes related to assigned studies, overseeing data collection workflows across all data sources, ensuring the quality and integrity of all clinical data including CRF and edit check specifications, Data Management Plans, data systems validation and UAT, listings generation, and review of clinical data for completeness, accuracy, and compliance. Based in San Francisco, CA or Cambridge, MA with 5% travel.

Responsibilities

• Day-to-day management of vendors involved in data management, ensuring quality of deliverables and that timelines are met
• Gather input from stakeholders and design data flow across data sources and across vendors
• Develop and review study plans and protocols to ensure data collection designs meet study objectives (e.g., System Validation Plans, Data Management Plans, Data Transfer Plans, Data Review Plans, Data Monitoring Plans, and Data Coding Guidelines)
• Develop and review specifications for database build and validation, edit checks, external system integration, or other systems and processes related to data while enabling near-real time data access for Olema clinical trials
• Ensure quality of clinical data by review for completeness, accuracy and consistency in accordance with study plans
• Support SAE reconciliation between clinical and pharmacovigilance databases and external data reconciliation within the clinical database
• Provide Clinical Data Management subject matter expertise to study team members during all phases of the project life cycle, including audits and inspections
• Lead a team of data management professionals
• Assist in the development and periodic review of Data Management SOPs, WIs, and templates while assessing metrics and implementing improvements

Qualifications

• Knowledge:
  • Bachelor‚Äôs degree or higher in science, biology, mathematics or computer science
  • CCDM certification preferred
  • Experience across early to late-phase clinical trials preferred; late-phase oncology experience required
  • Practical knowledge of MedDRA, WHODrug and/or another controlled thesaurus
  • Knowledge of Project Management Principles; PMP certification is a plus
  • Deep expertise in Excel and MS Office tools
  • Relational database understanding and SQL knowledge
  • Understanding of data manipulation using SAS, R, or Python/Pandas
• Experience:
  • 15+ years of experience in data management in the clinical trial industry (med device, pharma or biotech)
  • At least 5 years of experience managing data management professionals
  • In-depth understanding of clinical and data management regulations and guidelines (ICH, GCDMP, 21CFR Part 11, GDPR) and knowledge of CDISC/SDTM/SDTMIG standards
  • Experience managing data management CROs
  • Deep experience in reviewing clinical data
  • Hands-on experience with EDC systems (e.g., Rave, Veeva)
  • Experience building studies using CDISC/CDASH standards
  • Experience with data visualization tools (Spotfire, Tableau, RShiny, Dash)
  • Experience with management of data flow and curation of biomarker data is a plus
  • Experience with a programming language is a plus
• Attributes:
  • Excellent verbal and written communication skills; ability to advocate for a position and engage in vigorous debate
  • Analytical thinking with problem-solving skills; able to adapt to changing priorities and deadlines
  • Commitment to excellence
  • Collegial, hard-working, confident, self-starter with a passion for results
  • Fast learner who can identify core challenges and adapt in a fast-paced environment
  • Strong teamwork and collaboration; supports team success and shares expertise
  • Ability to make decisions with incomplete or ambiguous information and professional judgment
  • Professional ethics, integrity and judgment

Education

• Bachelor‚Äôs degree or higher in science, biology, mathematics, or computer science (as noted above)