Recursion · 2 weeks ago
Associate Director of Clinical Data Management
Recursion is a clinical stage TechBio company dedicated to improving lives through innovative science. The Associate Director of Clinical Data Management will lead end-to-end Clinical Data Management activities on assigned studies, manage third-party data sources, and collaborate with cross-functional teams to ensure effective data handling and compliance with regulatory standards.
Responsibilities
Lead End to End Data Management activities with hands on ability to manage outsourced studies and lead DM and external vendor oversight activities and deliverables.Proficiency in project management leading 3-4 outsourced programs, simultaneously
Represent Data Management function in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion regarding all data-related deliverables
Works with CRO and Recursion functional groups to complete EDC set up, database migrations /UAT and other systems such as IRT, ePRO etc. Manage multiple vendor sFTPs for data retrieval and delivery to stat programming, routinely
Establish Vendor Oversight Plans for all studies and responsible for Vendor Data Quality Reviews and Oversight. . Aim to harmonize processes where relevant with other Recursion clinical programs
Serve as a SME for various operational activities and DM processes like EDC, External data standardization, Collection, and Processing. Lead the efforts with Biometrics and Clin Dev organizations for creation and standardization of CRF’s Data Review Plans etc. Routinely provide study metrics, planning of deliverables, and propose solutions for data handling/related issues
Lead/Oversee the creation and maintenance of Data Management documents including, but not limited to, CDMP, CCG’s, Data Review Plans, edit checks, Listing review checks, Data Integrations specs, Data Transfer Specs, External Data Reconciliation plans, SAE Reconciliation Guidelines, Coding Guidelines, Database Lock, Checklists and Plans
Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements
Strategic and critical thinker who can independently lead initiatives and effectively collaborate cross functionally
Accountable for coordination with other functional groups for submission related activities
Manage strategic input into the design of data flow across EDC and non-EDC data sources across vendor networks
Ensure filing, archival and inspection readiness of all Data Management Trial Master File (TMF) activities
Review and manage external Data Management Budgets, ensure accuracy, and understand trends to support Budget planning and forecasting
Support the development of Clinical Data Management Standard Operating Procedures and Work Instructions
Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and CDM guidance documents
Qualification
Required
Bachelor's degree in science, math or computer science
12+ years' experience in the biopharmaceutical industry. Experience, technical proficiency and People management skills will determine the level
Experience managing external data and 3rd party vendors is a must
Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials
Excellent written and verbal communication skills and ability to work collaboratively as a part of a team
Benefits
Annual bonus
Equity compensation
Comprehensive benefits package
Company
Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives.
H1B Sponsorship
Recursion 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
2025 (6)
2024 (6)
2023 (5)
2022 (2)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$865.38MKey Investors
NVIDIAKinnevikLeaps by Bayer
2024-06-26Post Ipo Equity· $200M
2023-07-12Post Ipo Equity· $50M
2022-10-25Post Ipo Equity· $150M
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