Country Study Manager

Country Study Manager 

Position Purpose:

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 addition 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 overall 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 Teams 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 feasibility, 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 activities, investigator/site development activities or affiliate cross functional teams, etc.), as required.

Qualifications:

University degree or equivalent; preferably in a medical/science-related field and extensive experience and expertise in clinical research/development or related industry. Extensive experience in clinical trial project management.

Competencies:

Decision Making - identifies and understands problems and opportunities by gathering, analysing, and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints, and optimizes probable consequences.

Planning and Organizing (Achieving Results/Strategic Agility) - establishes an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines, and leveraging resources.

Communication - conveys information and ideas clearly and concisely to individuals or groups in an engaging manner that helps them understand and retain the message; listens actively to others.

Building Partnerships (Teamwork and Collaboration) - develops and leverages relationships within and across work groups to achieve results.

Influencing (Inspiring and Influencing) - uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.

Customer Orientation (Technical & Business Expertise) places a high priority on the internal or external customer's perspective when making decisions and taking action; implements service practices that meet the customer's and own organization's needs.

Coaching (Feedback and Coaching) — engages individuals in developing and committing to an action plan that targets specific behaviors, skills, or knowledge needed to ensure performance improvement or prepare for success in new responsibilities.

Work Standards - sets high standards of performance for self and others; assumes responsibility and accountability for successfully completing assignments or tasks; self-imposes standards of excellence rather than having standards imposed.

Innovation - creates novel solutions with measurable value for existing and potential customers (internal or external); experiments with new ways to solve work problems and seizes opportunities that result in unique and differentiated solutions.

Valuing Differences - works effectively with individuals ofdiverse cultures, interpersonal styles, abilities, motivations, or backgrounds; seeks out and uses unique abilities, insights, and ideas from diverse individuals.

Technical/Professional Knowledge and Skills has achieved a satisfactory level of technical, functional, and/or professional skill or knowledge in position-related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results.

Other:

Availability to travel domestically and internationally if required.

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 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 career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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