Clinical Trials Manager - III

Company Description

Job Description

• Must meet all requirements for Principal Clinical Trials Manager III position and have demonstrated proficiency in all relevant areas. 

• In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.

• Assists CPM in revising project timelines/budgets as necessary. 

• Works with management on departmental issues, providing input to clinical operations strategies and work plans.

• Contributes to development of abstracts, presentations and manuscripts.Participate in the recruiting and hiring process for CPA/CRAs and support their professional development.Participate in training of CPAs and CRAs. Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.

Qualifications

• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required. 

• Experience in developing RFPs and selection and management of CROs/vendors. 

• Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision

Additional Information

• Excellent verbal, written, interpersonal skills, and ability to lead multifunctional teams, ability to manage staff and mentor junior staff is required

• Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials is required