BlueRock Therapeutics

Biotech

AssociateDirector,DataManagement

$171–201k Cambridge, Massachusetts, United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“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.

Biotech
Problems you'll solve

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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