Clinical Data Manager Mid-Level (Remote)

Penfield Search Partners

Job Location:

Fairfield, OH - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Job Description

Contact: Neisha Camacho/Terra Parsons -
No 3rd party candidates

We are partnering with a growing biotech organization seeking a Clinical Data Manager to support ongoing and upcoming clinical programs across multiple Programs

This role will sit within a cross-functional clinical development team and support end-to-end data management activities with a strong focus on execution quality and collaboration. The ideal candidate brings solid hands-on data management experience with exposure to Phase II & III trials in a fast-paced biotech environment.

Key Responsibilities

Support clinical data management activities across studies from start-up through database lock
Partner with CROs and vendors to ensure high-quality timely data delivery
Collaborate cross-functionally with Clinical Biostatistics Programming and Medical teams on data collection and review strategies
Contribute to development and review of key deliverables including:

Data Management Plans (DMPs)
eCRF design and completion guidelines
Edit checks and query logic
User Acceptance Testing (UAT)
Data review and cleaning processes

Perform ongoing data review and support query management to ensure data quality and consistency
Support implementation of data standards and process improvements
Assist with inspection readiness and ensure compliance with regulatory requirements and industry standards

Qualifications

BS in a scientific or clinical discipline
58 years of clinical data management experience within biotech pharma or CRO environments
Hands-on experience with EDC systems (e.g. Medidata Rave Oracle Veeva)
Working knowledge of CDISC standards (SDTM/ADaM) and downstream data usage
Experience supporting Phase II or III clinical trials; CNS experience is a plus
Exposure to CRO/vendor oversight
Understanding of data structures and dictionaries (e.g. MedDRA WHODrug)
Strong collaboration skills and ability to work cross-functionally
Detail-oriented proactive and comfortable in a dynamic environment

Required Experience:

Manager

Job DescriptionContact: Neisha Camacho/Terra Parsons -No 3rd party candidatesWe are partnering with a growing biotech organization seeking a Clinical Data Manager to support ongoing and upcoming clinical programs across multiple ProgramsThis role will sit within a cross-functional clinical developme...