Manager of Clinical Data Management

Role Summary

Lead Clinical Data Manager responsible for end-to-end Clinical Data Management activities on assigned studies and programs. Manage 3rd party data sources and serve as SME for Data Management. Collaborate with cross-functional groups within the broader Data Science teams; oversee CDM study activities, document reviews, CRO oversight, timelines, and project risk management. Handle multiple projects in a fast-paced environment.

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 2-3 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.
• Establish Vendor Oversight Plans for all studies and responsible for Vendor Data Quality Reviews and Oversight. Harmonize processes where relevant with other Recursion clinical programs.
• Serve as a SME for operational activities and DM processes like EDC, external data standardization, collection, and processing. Lead efforts with Biometrics and Clin Dev organizations for creation and standardization of CRFs and Data Review Plans. Provide study metrics and deliverable planning; propose solutions for data handling/related issues.
• Lead the creation and maintenance of Data Management documents including CDMP, CCGs, Data Review Plans, edit checks, listing review checks, Data Integration specs, Data Transfer Specs, External Data Reconciliation plans, SAE Reconciliation Guidelines, Coding Guidelines, Database Lock, Checklists and Plans.
• Coordinate with other functional groups for submission-related activities.
• Provide 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 TMF activities.

Qualifications

• Required: Experience managing external data and 3rd party vendors.
• Required: Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
• Required: Excellent written and verbal communication skills and ability to work collaboratively as part of a team.

Education

• Bachelor’s degree in science, math or computer science.