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BlueRock Therapeutics · 15 hours ago

Associate Director, Data Management

Cambridge, MA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

7+ years exp

BlueRock Therapeutics is a clinical stage company focused on cell therapy for neurological and ophthalmic diseases. The Associate Director of Data Management will set strategic direction for clinical data management, overseeing data collection, coding, and validation processes to support statistical analysis and regulatory submissions.

BiopharmaBiotechnologyHealth CareMedical

H1B Sponsor Likely

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

Qualification

Data ManagementElectronic Data Capture (EDC)Clinical TrialsMedical DictionariesInterpersonal SkillsConflict ManagementNegotiation SkillsOrganizational SkillsTime ManagementAttention to Detail

Required

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

Company

BlueRock Therapeutics

It is a regenerative medicine company.

Founded in 2016

Toronto, Ontario, CAN

201-500 employees

http://www.bluerocktx.com

H1B Sponsorship

BlueRock Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2024 (3)

2023 (5)

2022 (3)

2020 (2)