Clinical Trials Manager II

Job 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. 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. Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus. Thank you. Kind Regards, Harris Kaushik Clinical Recruiter Integrated Resources , Inc. IT Life Sciences Allied Healthcare CRO DIRECT # - (650)-399-0891 Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5 0 0 0 ’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row) Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.