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Kelly Scientific Resources is a specialty service of Kelly Services®. As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines. Our scientists contribute to the research and development of therapeutics that change the lives of those affected with disease. We have an exciting contract opportunity in Foster City for a Clinical Trials Manager – II to join a leading biotherapeutics client.Clinical Trials Manager – IIDescription :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.Why Kelly ® ?With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.AboutKelly Services ®As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.
