Verastem Oncology · 5 hours ago
Director, EDC Operations
Boston, MA
Full-time
Onsite
Director/Executive
10+ years expVerastem Oncology is advancing innovation to address the needs of patients with cancers driven by RAS/MAPK pathway mutations. They are seeking an experienced Medidata Certified RAVE EDC leader to oversee EDC activities across multiple clinical programs, focusing on building in-house EDC capabilities and ensuring data integrity during oncology trials.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Oversee all EDC build activities from study start-up through database lock, as performed in-house or outsourced, working closely with the head of data management
Develop programming/configuration of RAVE, folders, edit checks, custom derivations, integrations (including IRT, pharmacovigilance, data visualization), migrations, and reports, based on protocol requirements
Set up Coder, Local Lab, RTSM, Targeted SDV modules, and any other applicable modules
Lead eCRF design and review meetings
Provide user support and technical support
Conduct end user training as appropriate
Work collaboratively with Head of Data Management
Lead, oversee and work effectively with vendor partners in user acceptance testing and deployment
Troubleshoots and resolves technical issues in a timely manner
Lead the defining, writing and updating of Rave CDMS SOPs. Establish work plans and best practices in conjunction with other functions including (but not limited to): quality, IT, data management
Develop and carry out plans to transition EDC activities from vendor(s) for selected studies as appropriate
Represent EDC activities, timelines, and deliverables at internal cross functional team meetings and meetings with external vendors
Support GCP inspection readiness
Qualification
Required
At least 10 years related experience in EDC systems/data management in the pharmaceutical/biotechnology/ CRO setting
Expert knowledge of EDC systems (including Medidata RAVE EDC/Classic platform)
Experience building and designing efficient EDC data management systems
Proficiency in understanding links between EDC and other Clinical Trial/Data Management Systems
Understanding of clinical trial processes and data management
Certified Medidata RAVE builder
Knowledge of SQL required
Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH
Overall understanding of ICH, GCP as well as general knowledge of industry practices and standards
Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
Knowledge of coding dictionaries (MedDRA, WHO Drug)
Excellent verbal and written communication skills as well as interpersonal and organizational skills
Strong attention to detail & problem-solving, ability to prioritize and handle multiple projects
Proficiency in MS Office applications
Preferred
BA/BS in scientific or health care field
Experience in oncology indication
Familiarity with medical terminology
Benefits
Annual bonus
Equity compensation
Competitive benefits package
Company
Verastem Oncology
Verastem is a biopharmaceutical company developing new medicines to improve the lives of patients with RAS/MAPK pathway-driven cancers.
51-200 employees
H1B Sponsorship
Verastem Oncology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (1)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$626.6MKey Investors
RTW InvestmentsOberland CapitalBiotechnology Value Fund
2025-11-14Post Ipo Equity· $90M
2025-04-25Post Ipo Equity· $75M
2025-01-13Post Ipo Equity· $7.5M
Leadership Team
Dan Paterson
President and CEO
Dan Calkins
Chief Financial Officer
Recent News
Boston Globe
2026-01-03
2026-01-03
Company data provided by crunchbase