Roche Pharmaceuticals looking for Country Study Manager

 

Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.

Post : Country Study Manager

Job Description:
The Country Study Manager (CSM) will provide leadership and 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.

• You will have full accountability and oversight for all assigned studies at country level (Global and local studies) in accordance with the overall project plan, manage and maintain accurate country/study level plans (e.g. timelines, budget, resource, risk and quality plans) in the appropriate Roche planning system
• You will highlight deviations and risks in plans to relevant parties, develop and implement mitigation strategies as required, lead local study teams, represent Country/Region Clinical Operations at the global SMT, and provide Global teams with feedback from an Affiliate perspective
• You will plan and execute country study goals and commitments, ensure compliance to relevant processes and coach & provide support to responsible study team members
• You will provide study oversight, leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery at the country and site level, and interface with CRO Management regarding feedback on CRO staff performance as required
• You will oversee study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensure eTMF completeness and oversight of all relevant compliance activities for allocated studies
• You will collaborate 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.

Candidate Profile
• You have a University degree or equivalent, preferably in medical/science-related field and extensive experience (10 – 15 years) and expertise in clinical research/development or related industry & clinical trial management
• You are someone who identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information
• You set high standards of performance for self and others, assume responsibility and accountability for successfully completing assignments
• You are someone who creates novel solutions with measurable value for existing and potential customers

Additional Information
Location : Maharashtra, Mumbai Bandra East
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th December, 2018

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