Manager, Database Programming

Veristat•Massachusetts, MA

7d•$100,000 - $115,000•Remote

About The Position

The Manager, Clinical Database Programming is responsible for the operational leadership of Veristat’s Clinical Database Programming (CDP) team(s), the support of study level strategy, and the development of Clinical Data Management Systems (CDMS) in compliance with statutory regulations and Veristat Standard Operating Procedures. Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. 105+ approved therapies for marketing applications prepared by Veristat 480+ oncology projects in the past 5 years 350+ rare disease projects delivered in the past 5 years Flexible, inclusive culture — 70% remote workforce, 66% women-led teams Learn more about our core values here!

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.

Nice To Haves

Knowledge of and experience programming SAS preferred.

Responsibilities

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