Manager, Database Programming

Role Overview

• 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.

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