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.
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.