Job Details
- Title: Clinical Trial Manager
- Code: RCI-07510
- Location: Foster City California (CA) 94404
- Posted Date: 12/02/2019
- Duration: 12 Months
Talk to our Recruiter
- Name:Mangesh Kanade
- Email: mangesh.kanade@rangam.com
- Phone: 908-704-8843 ✖ 260
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