Manager/Associate Director Clinical Data Management
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 Manager/Associate Director of 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 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. On a daily basis, 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, eCOA 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 network.
- 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 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
The Values That We Hope You Share:
- We Care: We care about our drug candidates, our Recursionauts, their families, each other, our communities, the patients we aim to serve and their loved ones. We also care about our work.
- We Learn: Learning from the diverse perspectives of our fellow Recursionauts, and from failure, is an essential part of how we make progress.
- We Deliver: We are unapologetic that our expectations for delivery are extraordinarily high. There is urgency to our existence: we sprint at maximum engagement, making time and space to recover.
- Act Boldly with Integrity: No company changes the world or reinvents an industry without being bold. It must be balanced; not by timidity, but by doing the right thing even when no one is looking.
- We are One Recursion: We operate with a 'company first, team second' mentality. Our success comes from working as one interdisciplinary team.
Recursion spends time and energy connecting every aspect of work to these values. They aren’t static, but regularly discussed and questioned because we make decisions rooted in those values in our day-to-day work. You can read more about our values and how we live them every day here.
More About Recursion
Central to our mission is the Recursion Operating System, or Recursion OS, that combines an advanced infrastructure layer to generate what we believe is one of the world’s largest and fastest-growing proprietary biological and chemical datasets and the Recursion Map, a suite of custom software, algorithms, and machine learning tools that we use to explore foundational biology unconstrained by human bias and navigate to new biological insights which may accelerate our programs. We are a biotechnology company scaling more like a technology company. Recursion is proudly headquartered in Salt Lake City.
Learn more at www.recursion.com, or connect on Twitter and LinkedIn.
Recursion is an Equal Opportunity Employer that values diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
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