Job Description:
• 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.
• 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.
• Performs/coordinates for Health Authority presentation for the study/ protocol amendments.
• 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.
Functional Competencies:
• Decision Making
• Planning and Organizing (Achieving Results/ Strategic Agility)
• Communication
• 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)
• 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
• Technical/Professional Knowledge and Skills
• Decision Making
• Planning and Organizing (Achieving Results/ Strategic Agility)
• Communication
• 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)
• 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
• Technical/Professional Knowledge and Skills
Behavioral Competencies:
• Patient centricity in decision making
• Building Partnerships (Teamwork and Collaboration) - develops and leverages relationships within and across work groups to achieve results.
• Inspiring and Influencing
• Valuing Differences - works effectively with individuals of diverse cultures, interpersonal styles, abilities, motivations, or backgrounds; seeks out and uses unique abilities, insights, and ideas from diverse individuals.
• Patient centricity in decision making
• Building Partnerships (Teamwork and Collaboration) - develops and leverages relationships within and across work groups to achieve results.
• Inspiring and Influencing
• Valuing Differences - works effectively with individuals of diverse cultures, interpersonal styles, abilities, motivations, or backgrounds; seeks out and uses unique abilities, insights, and ideas from diverse individuals.
Additional Information
Location : Maharashtra, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Operations
End Date : 30th March, 2019
Location : Maharashtra, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Operations
End Date : 30th March, 2019
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