Associate Director of Clinical Data Management

Role Summary

Associate Director of Clinical Data Management responsible for leading end-to-end Clinical Data Management activities on assigned studies and programs, managing 3rd party data sources, and serving as SME for Data Management within Biometrics. Lead and deliver CDM initiatives, collaborate with cross-functional groups, oversee CROs, timelines, and risk management across multiple projects in a fast-paced environment. Based in Salt Lake City or New York City with a hybrid in-office requirement (50%).

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.
• Work 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‚Äôs 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‚Äôs, 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.

Qualifications

• Bachelor‚Äôs degree in science, math or computer science
• 12+ years‚Äô 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.

Education

• Bachelor‚Äôs degree in science, math or computer science

Additional Requirements

• Working Location: Salt Lake City or New York City; hybrid environment (50% in office).
• Relocation support can be provided.