BlueRock Therapeutics
Biotech
AssociateDirector,DataManagement
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“Associate Director, Data Management at BlueRock Therapeutics. Skills: Clinical data management, Data cleaning, Vendor oversight. Lead data management efforts. Coordinate study start-up activities”
What You'll Achieve.
Deliver data with good quality; Deliver data within expected timelines
Industry & Context.
Issue resolution
What They're Looking For.
Must Have
7 years Data Management experience, 4 years leading or vendor oversight experience, B.S./B.A. in scientific discipline, Experience with MedDRA, Experience with WHODrug, Proficient with EDC systems, Proficient experience in outsourced data management model
Nice to Have
PhD preferred
What You'll Do.
Lead data management efforts
Coordinate study start-up activities
Coordinate interim data cuts
Coordinate close out activities
Represent data management function
Lead data review meetings
Perform data cleaning
Manage query resolution
Review medical coding
Oversee external lab data reconciliation
Reconcile external data
Author data transfer agreements
Lead database lock activities
Oversee database lock activities
Supervise data managers
Lead eCRF development
Facilitate cross-functional reviews
Oversee database building
Review edit check specifications
Lead user acceptance testing
Perform user acceptance testing
Monitor data collection by CROs
Monitor data cuts by CROs
Monitor coding by CROs
Monitor cleaning by CROs
Perform targeted data reviews
Review data management plans
Review CRF completion guidelines
Review external data transfer specifications
Ensure data management documents are completed
File data management documents in eTMF
Perform data review using visualization tools
Perform quality check data using visualization tools
Review clinical study protocols
Review statistical analysis plans
Support Data Management metrics
Assist in SOP development
Assist in working instruction development
Assist in job aid development
How You'll Work.
Team & Collaboration
Cross-functional teams; Cross-functional meetings
Communication Scope
Verbal communication; Written communication
Process & Methodology
Roadmap planning
Full Job Description
## Description Who is BlueRock? BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases. The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology. What Are We Doing? Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives. Description of Position: This position will lead clinical data management activities for programs or projects, representing clinical data management function on internal and external teams. This position is also responsible for the oversight and quality check of the clinical data management tasks performed by a CRO, coordination of internal cross-functional team data rev
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