Senior Clinical Trials Manager - Permanent - Cambridge, MA
Proclinical is seeking a Senior Clinical Trials Manager to join our client's team on a permanent basis.
Primary Responsibilities:
The successful candidate will focus on managing clinical trials for oncology product candidates, ensuring all operational deliverables are met within timelines and budgets. This position requires collaboration with various stakeholders and oversight of Contract Research Organizations (CROs).
Skills & Requirements:
- Advanced degree or equivalent in life sciences or healthcare.
- Experience in clinical development and cross-functional clinical trials.
- Preferred experience as a Clinical Research Associate.
- Knowledge of Good Clinical Practice (GCP) and clinical trial design.
- Basic knowledge of oncology is preferred.
The Senior Clinical Trials Manager's responsibilities will be:
- Ensure operational trial deliverables meet timelines, budget, and quality standards.
- Assist in authoring protocols and developing study tools and training materials.
- Manage clinical study materials and oversee vendors and third parties.
- Implement risk management and data review processes.
- Drive enrollment and recruitment activities.
- Support trial budget development and tracking.
- Lead internal operations and co-lead Clinical Trial Team meetings.
- Manage site-related issues and support the development of Case Report Forms.
- Assist with program-level activities and regulatory document development.
- Participate in CRA calls and assist with site follow-up and training.
- Review Trial Master File (TMF) and assist with remediation.
- Manage site engagement and relationships through communication and visits.
- Review Monitoring Trip Reports and track comments and actions.
- Participate in oversight monitoring visits at clinical trial sites.
If you are having difficulty in applying or if you have any questions, please contact Nico Kohlwes at n.kohlwes@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
