Associate Director, Data Management

BlueRock Therapeutics•Cambridge, MA

20h

About The Position

This position will lead clinical data management activities for programs or projects, representing the 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 issue resolutions, to ensure the data deliverables with good quality and within the expected timelines for statistical analysis, publications and regulatory reports/submissions. Reporting to the Senior Director, Data Management, this position may assist in developing SOPs, working instructions, job aids, etc., to align with the corporate strategic plan for the clinical data management department.

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

Responsibilities

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