Associate Director, Data Management

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 set strategic direction for supporting the clinical data management and systems. Reporting to the Director, Data Management, this position assists in the implementation of the corporate strategic plan in the data management department and manages all priorities and workload in data management. This position is also responsible for the oversight of clinical data management tasks to collect, code, process, review, and validate data to support statistical analysis, study results publications and regulatory submissions, participates in SOP development as well as oversees the activities of CRO data management teams to ensure deliverables are met with quality. 

Responsibilities

• Lead relevant data management efforts to coordinate study start-up activities, interim data cuts to support various activities
• Oversee database lock activities and ultimate archiving of study data
• May help in directing the overall data management standards and processes in a particular therapeutic area/program
• Review clinical study protocols and statistical analysis plans in the assigned therapeutic area (TA)
• Lead eCRF development and facilitate cross-functional reviews of eCRF content
• Oversee and direct database building activities, including review of edit check specifications and performance of user acceptance testing
• Monitor data collection, data cuts, coding, and cleaning by CROs through tracking of study metrics and targeted data reviews
• Review data management plans, CRF completion guidelines, external data transfer specifications and other study documentation in the assigned TA
• Represent data management in cross-functional meetings at the TA level
• May help in the SOP’s, checklists, templates development for data management by working with Director, Data Management
• May/Mayn’t oversee Data Managers on the assigned studies and may perform hands-on (overseeing) data management work
• May support the Director, Data Management on initiatives relevant to Imaging data, Biomarker data, Digital Health Technologies (DHT’s) data etc.,
• May support the Director, Data Management in evaluating DM relevant tools like reporting tools, data visualization tools, eConsent, etc.,
• Participates in other activities and meetings to support Data Management/Biometrics as necessary

Requirements

• Excellent interpersonal skills and good conflict management and negotiation skills
• B.S. / B.A. in scientific discipline (minimum undergraduate degree required), with 7 years of Data Management experience and a minimum of 4 years of line management experience
• Experience with medical dictionaries, including MedDRA and WHODrug
• Proficient with electronic data capture (EDC) systems like Veeva EDC, Medidata-RAVE and the development of CRF/eCRF for clinical trials and its impact in database design/development
• Excellent organizational and time management skills with great attention to details