Director, Clinical Data Management

Role Summary

As the Director of Clinical Data Management, reporting to the Sr. Director, Clinical Data Management, you will be responsible for all data processes related to assigned studies, overseeing data collection workflows across 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, as well as ensuring review of clinical data for completeness, accuracy, and compliance. This role is based in either San Francisco, CA or Cambridge, MA and will require 5% travel.

Responsibilities

• Day-to-day management of vendors involved in data management, to ensure quality of deliverables and that SET 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 that data collection designs meet study objectives (i.e., 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 internal and external audits and inspections
• Lead a team of data management professionals
• Assist in the development and periodic review of Data Management specific SOPs, WIs, and templates while assessing metrics and implementing suggested improvements

Qualifications

• Knowledge: 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; a PMP certification is a plus
• Deep expertise in Excel and MS Office tools
• Relational database understanding and SQL knowledge
• Understanding of data manipulation, for example using SAS, R, or Python/Pandas

Experience

• 15+ year experience in data management in 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 functional knowledge of CDISC/SDTM/SDTMIG standards
• Experience managing data management CROs
• Deep experience in reviewing clinical data
• Hands-on deep experience working with EDC systems (e.g. Rave, Veeva)
• Practical experience building studies using CDISC/CDASH standard
• Experience with data visualization tools (Spotfire, Tableau, RShiny, Dash)
• Experience with management of data flow and curation of biomarker data a plus
• Experience with a programming language a plus

Attributes

• Excellent verbal and written communication and skills, coupled with the ability to advocate for a position and engage in vigorous debate to reach the best decision
• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
• A commitment to excellence
• Collegial, hard-working, confident, a self-starter and have a passion for results
• A fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
• Strong teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
• A demonstrated ability to make decisions in situations where there is incomplete or ambiguous information and where there is a high degree of professional judgment required
• A “difference maker” in terms of one’s professionalism and contributions
• Impeccable professional ethics, integrity and judgment

Education

• Bachelor’s degree or higher in science, biology, mathematics or computer science

Additional Requirements

• Travel: up to 5% of time