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1+ months

Country Studies Manager IV

Kelly Services
South San Francisco, CA 94080
Country Studies Manager IV



Duties: The Country Study Manager (CSM) provides leadership and regional/local strategic planning and operational delivery of assigned clinical studies through all phases of study management. (preparation, study start-up, conduct, close-out), in accordance with Roche quality standards, all applicable regulations, timelines and budget commitments.





For Global/Regional Studies (referred as Global), the CSM leads and has full accountability (time, quality, cost) in alignment with the Study Management Team (SMT) For Local Studies, the CSM acts as study leader and, in additiona to the above, provides the leadership and clinical operational expertise for the local study team.





Main Responsibilities and Accountabilities:





Has full accountability and oversight for all assigned studies at regional/country level (Global and local studies) in accordance with the overal project plan, manages and maintains accurate country/study level plans (e.g. timelines, budget, resource, risk and quality plans) in the appropriate Roche planning system.



Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.



Leads local study teams, represents Country/Region Clinical Operations at the global SMT, and provides Global Team with feedback from an Affiliate perspective (Global).



Plans and executes country study goals and commitments, and ensures compliance to relevant processes.



May serve as global Country Study Representative (gCSR), as part of global study team.



Coaches and provides support to responsible study team members.



Provides study oversight, leadership and support to Contract Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.



Oversees study fesibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.



Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.



Develops and maintains optimal site relationships with key investigator sites, alliance partners, and/or collaborative group for current and future Roche studies.



Participates in overall Therapeutic Area support together with the therapeutic leads and country experts (e.g. landscaping activites, investigatgor/site development activities or affiliate cross functional teams etc.) as required






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 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 careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-02-14 Expires: 2020-04-16

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Country Studies Manager IV

Kelly Services
South San Francisco, CA 94080

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