AD/Director, Clinical Data ManagementApply Now
Location: Cambridge, Massachusetts 02139
Employment Type: Direct Hire
Reporting to the Head of Clinical Data Management, the Associate/Director, Clinical Data Management will be responsible for leading the data management processes for the Rare Disease therapeutic area.
Here’s What You’ll Do:
- Lead the data management partnership with CROs for studies in the Rare Disease therapeutic area
- Work effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics and data review tools
- Oversee the activities of CRO DM functional counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality
- Perform thorough development testing of the eCRF prior to deployment, inclusive of User Acceptance Test (UAT) Plans, Test Scripts and execute testing applicable
- Implement, track and review key performance indicators on data management activity across the Rare Disease program
- Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review and reporting in compliance with GCP, SOPs and regulatory requirements
- Participate in the Data Standards Committee and act as the liaison between the study team members Rare Diseases to standardize data collection and reporting
Here’s What You’ll Bring to the Table:
- Master’s or bachelor’s degree in computer science or a science-based subject with at least 10 years of clinical data management experience in industry, with experience across indications and EDC platforms (or Doctorate with at least 5 years of experience in industry); or a bachelor’s degree outside of computer science or a science-based subject with a minimum of 12 years of clinical data management experience in industry, with experience across indications and EDC platforms
- At least 3 years of management experience in a clinical research environment, most of which should be in industry and preferably across therapeutic areas
- Vendor management and oversight experience
- Strong technical skills across data platforms
- Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
- Cross collaboration proficiency with other departmental functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
- Thorough command of FDA and ICH GCP guidelines to ensure the appropriate reporting of clinical trial data
- Experience in regulatory GCP inspections/audits
- Outstanding verbal and written communication skills, in addition to excellent organizational skills
- Ability to manage multiple projects in a fast-paced environment
- Creative, capable problem-solver
Great benefits such as
- Daily on-site catered lunches
- Company-provided iPhone
- Free parking, monthly subway pass or a subsidized commuter rail pass
Yhoumey is a recruiter for our direct hire team. She enjoys partnering with candidates to find the right career placements.
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