Job Details

Must meet all requirements for Clinical Trials Manager 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
• Coaches members of a work team and ensures adherence to established guidelines
• Provide input to program budget and timelines to ensure successful management of all aspects of international clinical trials
• Anticipates obstacles and client difficulties and implements solutions to achieve project goals
• Assists CPM in revising project timelines/budgets as necessary
• Works with management on departmental issues, providing input to clinical operations strategies and work plans
• Communicates with functional peers regarding project status and issues and ensure project team goals are met
• 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
• Excellent interpersonal skills and demonstrated ability to lead is required
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction
• Strong communication and influence skills and ability to create a clear sense of direction is necessary
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction
• Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials

• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required
• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training
• 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
• Ability to examine functional issues from a broader organizational perspective
• Travel is required