Manager, Database Programming
Location
Massachusetts
Posted
6 days ago
Salary
$100K - $115K / year
Seniority
Lead
Job Description
Manager, Database Programming
Veristat
• Responsible for the operational leadership of Veristat’s Clinical Database Programming (CDP) team(s). • Support of study level strategy. • Development of Clinical Data Management Systems (CDMS) in compliance with statutory regulations and Veristat Standard Operating Procedures.
Job Requirements
- Bachelor’s (or equivalent) degree in related field preferred or 8 years of relevant experience as a database programmer required.
- 8 years of clinical data management and/or clinical database programming experience (including leading projects) required.
- 3 + years of supervisory experience or 5+ years of lead experience required.
- Extensive experience working for a pharma/biotech sponsor or clinical CRO with specific focus on developing and implementing EDC and web reporting tools.
- Demonstrated ability to lead by example and demonstrated skill for technical and supervisory leadership of staff.
- Excellent written and oral communication skills including grammatical/technical writing skills and presentation skills.
- Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical/biotech companies.
- Excellent interpersonal, communication, and organizational skills with the ability to work independently as well as in a team environment.
- Experience in, and awareness of, current and emerging EDC systems.
- Proven track record at delivering projects on time and within budget.
- Extensive knowledge of software validation within a clinical research environment.
- Experience of data management principles as applied in an EDC environment.
- Ability to develop the best project management tools and use of software appropriate to delivery of such a project.
- Knowledge and experience of industry regulations and guidelines as pertaining to EDC system deployment and support specifically 21 CFR Part 11.
- Knowledge of and experience with implementing CDISC standards.
- Knowledge of and experience programming SAS preferred.
Benefits
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
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