Science Jobs

Clinical Data Manager

Discovery / Clinical
  • Job ID: 19144
  • Direct Hire
  • MA
Email

HireMinds Biotech team is engaged to find a Clinical Data Manager for a growing biotech company who are focused within the Oncology space! This is an exciting and visible role if you are results-driven, highly organized and have a proven track record in Human Resources within the pharma/biotech industry.

 

**This person will need to be able to come onsite to the office 1-2x per week in Waltham, MA**

 

In This Role You Will Be Responsible For:

  • Provide clinical study level data management oversight of outsourced clinical trials for phase I / II studies including: project management, vendor management, coordination of internal reviews, and approval of deliverables.
  • Oversee database design and production, ensuring that CROs, vendors and internal staff meet the highest quality standards, ensuring complete, correct and consistency of clinical data and outputs.
  • Act as liaison with CROs, third party data vendors, and EDC vendors.
  • Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed and communicate project status and issues.
  • Assist as author/reviewer for eCRFs, eCCGs, and Data Management Plans.
  • Review data analysis listings and report on performance and quality; review clinical data within studies and across programs for trend analysis.
  • Accountable for external data vendor documentation, management, and reconciliation.
  • Assist as needed with clinical documents such as clinical protocols, investigator brochure updates, annual reports and status updates.
  • Collaborate with Clinical Operations to ensure the data management component of the eTMF is maintained appropriately throughout the trial.

 

You Will Bring the Following Requirements:

  • B.S. degree in a Biomedical Science or equivalent.
  • 3-5 years of relevant clinical data management experience, with a minimum of 2 years in oncology trials, in a CRO or bio/pharmaceutical setting.
  • Ability to collaborate effectively with the cross-functional study team and external partners using collaborative negotiation skills.
  • Working knowledge and experience with FDA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide coding dictionaries such as MedDRA.