Associate Director of Clinical Data Management

Recursion

73d • $189,000 - $244,000

About The Position

Recursion is seeking an Associate Director, Clinical Data Management who can lead and oversee end to end Clinical Data Management activities on assigned studies and programs. You’ll also play a critical role in the management of all the 3rd party data sources and serve as SME for Data Management. You’ll be responsible for leading and delivering initiatives for CDM within the Biometrics group. You’ll also be proactive and be keen to collaborate with cross functional groups within the Clinical Development organization and larger Data Science teams at Recursion. Daily, you will be responsible for all the CDM study activities and deliverables, document reviews, oversight of CRO’s, timelines and project risk management. You can expect to work on multiple projects at the same time in a fast-paced and exciting environment.

Requirements

• Bachelor’s degree in science, math or computer science.
• 12+ years’ experience in the biopharmaceutical industry.
• 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.

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’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.
• 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.

Benefits

• Annual bonus and equity compensation.
• Comprehensive benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees