Manager of Clinical Data Management

Role Summary

Lead, Clinical Data Manager who can lead and oversee end to end Clinical Data Management activities on assigned studies and programs. Manage all 3rd party data sources and serve as SME for Data Management. Collaborate on clinical development initiatives with cross functional groups within the larger Data Science teams. Responsible for all CDM study activities and deliverables, document reviews, oversight of CROs, timelines and project risk management.

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, 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 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.

Qualifications

• Bachelor‚Äôs degree in science, math or computer science
• 8 - 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

Skills

• Clinical Data Management
• EDC systems, data standards, data integration
• Vendor management and CRO oversight
• Project management
• Data quality assurance and TMF readiness

Education

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

Additional Requirements

• Location: Salt Lake City or New York City area