The Electronic Data Capture (EDC) system programmer / data manger will be supporting multiple facets of Clinical Development, with focus on developing and implementing EDC systems for clinical trial and lead the data management aspects for ongoing studies. The candidate will work under the direction of the Executive Director of Research & Strategy to support the progress of the company pipeline. The candidate will have a general knowledge of Drug Development principles and be able to work collaboratively with related disciplines such as pharmaceutical development, regulatory, clinical operations, data analysis, and reporting.
Responsibilities:
- As a member of the project team, support the overall clinical development strategy for an asset or program
- Lead EDC development and data management
- Provides quality input, advice, and opinion on clinical studies including data capture, quality and analysis
- Provides input into study conceptualization, and protocol development in collaboration with the project team
- Provides cross-functional support to clinical operations, regulatory, and CMC
- Supports the development of trial execution strategy for the specific indication
- Contributes to regulatory documents including CSRs, Investigator’s Brochures, and Clinical sections of INDs, CTAs and/or NDAs
- Collaborate and liaise with CROs, KOLs, vendors, contractors, and consultants
Qualifications:
- Master degree a scientific discipline
- 2 years or more of experience with programming / implementation of Medidata, Red Cap Cloud or other main commercial part 11 complient EDC systems
- 2 years or more of experience in the Biotechnology / Pharmaceutical Industry
- 2 years or more of experience with clinical development in neurology and/or psychiatry - preferred
- Knowledge of regulatory guidelines and ICH/GCP
What we look for in our people:
- Highly motivated self-starter with an entrepreneurial spirit and commitment to personal and career development
- Desire to work in a quickly changing and fast-paced growing business
- Unrelenting dedication to delivering results and a desire to shape the strategic goals of the business. Willing to roll up your sleeves to get the job done
- Ability to overcome ambiguity and challenge the status quo
- Manage multiple programs with competing and aggressive timelines, prioritize activities, and work independently
- Excellent written and oral communication skills; experienced presenter of key messages to broad audiences including Senior Stakeholders
As an equal opportunity employer, Neurocentria is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
