Clinical Trials Manager - II

I T Solutions Inc Foster City, CA
Title: Clinical Trials Manager II
Location: Foster City
Type: Contract

Description:
  • 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.