Clinical Trials Manager - II
I T Solutions Inc Foster City, CA
Title: Clinical Trials Manager II
Location: Foster City
Location: Foster City
- Must meet all requirements for Principal Clinical Research Associate 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.
- 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.
- Travel is required.
- 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.
- 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.
- Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.