Manage clinical data management efforts, oversee database activities, develop eCRF content, and direct CRO data management teams to ensure quality deliverables.
Who is BlueRock?
BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.
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.
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
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 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
#LI-AL1
BlueRock Therapeutics Company Culture Highlights
Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023
Winner of Comparably's Award for Best Company for Diversity 2022
Winner of Comparably's Award for Best Company for Women 2022
Winner of Comparably's Award for Best CEO 2022
BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.
Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.
Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics
Follow us on Linkedin: https://www.linkedin.com/company/bluerocktx/
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.
Top Skills
Electronic Data Capture
Medidata-Rave
Veeva Edc
BlueRock Therapeutics Cambridge, Massachusetts, USA Office
1 Broadway, , Cambridge, MA, United States
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