Associate Director, Data Management

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 review activities to the issue resolutions, to ensure the data deliverables with good quality and within thew expected timelines for statistical analysis, publications and regulatory reports/submissions.

Reporting to the Senior Director, Data Management, this position may assists in the developing SOP, working instruction, job aid etc. to align with the corporate strategic plan for the clinical data management department.

 

Responsibilities:

· Lead data management efforts to coordinate study from start-up activities, interim data cuts to support various activities, to close out activies

· Represent data management function at cross-functional meetings

· Lead regular data review meetings in a cross-functional team environment.

· Responsible for data cleaning, query and resolutions, review of medical coding

· Oversee or responsible for external lab data reconciliation, manage and reconcile external data, authoring data transfer agreements

· Lead or oversee database lock activities and ultimate archiving of study data

· Supervise and mentor supporting data managers to ensure data management activities are conducted as expected

· Lead eCRF development and facilitate cross-functional reviews of specification

· Oversee and direct database building activities, including review of edit check specifications, lead and perform the 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, ensuring all data management documents are completed and to be filed in the study eTMF and are ready for regulatory inspection

· Using data visualization tools to perform data review or quality check data with cross function teams

· Review clinical study protocols and statistical analysis plans

· Participates in other activities and meetings to support Data Management/Biometrics as necessary

· Support in the SOP’s, working instruction, templates development for data management head of the Data Management

 

Minimum 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 leading or vendor oversight 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

· Proficient experience working in an outsourced data management model.

· Excellent verbal and written communication, organization and time management skills

 

Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.