Data Management Analyst needed for an on site 12 month contract in the Boston area.
Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
10+ years relevant work experience with a focus on data management, Clinical Database Programming, Deep understanding of drug development and biopharmaceutical industry required
5-7 years of UAT experience
10 Years of overseeing CRO
10 years of working at Pharmaceutical or Biotech
Develops program timeline and monitors data deliverables for all studies within assigned program in collaboration with cross functional team members and vendors.
- Develops/Interprets and applies data strategy, verifies consistency and usage of data standards
- Coordinates and oversees outsourced personnel, and monitors and reports on overall study/program progress. Accountable for overall quality of study data.
- Develops risk mitigation or action plans and oversees execution when appropriate.
- Serves as a contact representing DM within Biometrics and clinical study management teams (SMT and/or Clinical Development Team representatives). Liaises directly with internal customers (Biometrics functions, GCO, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel)
- Serves as Subject Matter Expert alongside Biometrics counterparts for data, reporting, and analysis process definition, improvement, and innovation as needed
- Manages performance and quality issues with vendors and escalates to vendor managers and Management and develops appropriate risk mitigation as needed
- Support study-level audit and inspection readiness activities as needed
- Serve as project manager on special projects and initiatives; partners with Statistical Programming, VM and Quality depending on type of project
- Deep understanding of drug development and biopharmaceutical industry required
- Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
- Knowledge of GCP and other regulations
Job Type: Contract
Salary: $75.00 to $90.00 /hour
- UAT: 7 years (Preferred)
- Managing Studies: 7 years (Preferred)
- Overseeing CRO: 9 years (Preferred)
- United States (Preferred)