Clinical Data Manager

Your work will change lives. Including your own. 

The Impact You’ll Make

Recursion is at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking a Lead, Clinical Data Manager 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. In this role, you will:

• Lead End to End Data Management activities for outsourced studies and manage DM and external vendor oversight activities and deliverables.
• Represent Data Management function at Clinical Study Meetings and ensure alignment of expectations between the CRO and Recursion for all the data related deliverables.
• Works with CRO and Recursion functional groups to complete EDC set up and other systems such as IRT, ePRO etc.,
• Establish Vendor Oversight Plans for all studies and responsible for Vendor Data Quality Reviews and Oversight.
• 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.
• Leads/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.
• 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.

 

Location

Making Salt Lake City your home base is ideal, however, we will consider remote work for this position. We ask that remote employees commit to regular on-site visits for routine work and departmental events.

 

 The Team You’ll Join

Reporting to the Senior Director, Clinical Data Management and working closely with Biometrics, Clinical Operations and Clinical Development Organization, you will be an essential member of the Recursion Development Team. The Development Team is an empowered, execution-minded group of drug development professionals responsible for translating Recursion’s innovative science to patients through clinical development activities.

 

 The Experience You’ll Need

•  Bachelor’s degree in science, math or computer science
• 8 - 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

 

How You’ll be Supported

• You will be offered ample support from the Head of Clinical Data Management with respect to onboarding within Recursion and more specifically within CDM, Biometrics and ClinDev organizations.
• Opportunity to collaborate with cross functional leaders across Recursion and be part of the tech-bio revolution.
• Opportunity to make a meaningful impact on patients’ lives.
• Option to participate in coaching like BetterUp for leadership skills and development programs.
• Option to attend conferences to learn more from colleagues, networks, and more to better your skillset. 

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