ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT

Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex trials with a CRO and supporting upcoming submissions. The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project team and the CROs.

This role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)

Responsibilities (including, but not limited to):

• Drive and lead the development of all databases and eCRF design


• Plan, develop and implement UAT (user acceptance testing), data specifications, data entry guidelines, CRF completion guidelines, and related operational manuals/guidelines


• Develop and execute data validation guidelines and measures to ensure accurate data gathering from clinical studies


• Review and provide expertise on all eCRF changes, respond accordingly to make resulting database changes


• Organize and direct the initial stage of the studies, review and sign off on various items such as eCRF, data validation, data review guidelines, and data management plans


• Oversee and build strong sustainable relationships with multiple global CROs/vendors along with managing the process and coordination of each


• Accountable for ensuring all data quality and timeliness of CDM deliverables are met and aligned with the business goals; Coordinate with all functions to drive data cleaning


• Review, track, and report status of all data management project(s) to senior leadership


• Responsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliation


• Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF)


• Partner with cross functional key stake holders to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting; Serve as internal expert on data management with vendors


• Develop data management SOPs and processes that align and address business priorities; Contribute to cross-functional SOP development


• Uphold a reputation for data integrity and compliance

Requirements