Clinical Study Manager

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The Position

Job Title: Clinical Study manager- local studies

Location: (HO) Mumbai

Role Summary: Provides leadership to study team, local strategic planning and operational delivery of assigned local 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.

How does the role serve the patients?

• Provides hands-on experience to KOLs on Innovative treatment through local phase 4, non-interventional studies, Investigator initiated studies, Real world evidence generation, Compassionate use program, Post trial access program.
• By providing early access to innovative treatment to Indian patients.
• By generating robust safety as well as efficacy data on Indian patients through participation in the clinical trials which in turn facilitates regulatory approvals for Roche Innovative products.

Accountabilities

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

• Leads local study teams, represents Country /Region Clinical Operations at the global SMT, and provides global teams with feedback from an Affiliate perspective
• Works with relevant global study team to manage day to day activities of the study, including monitoring report review, problem solving, issues escalation , timely closure of non-productive studies and tracking of safety procedures
• Plans and executes country study goals and commitments, and ensures compliance to relevant processes, Roche quality and safety standards, regulations, timelines and budget commitments.
• Provides operational oversight of Investigator-initiated studies and Compassionate Use studies in terms of Roche quality and safety standards, regulations, timelines and budget allocation.
• Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.
• Coaches and provides support to responsible study team members by maintaining effective communication
• Provides study oversight, leadership and support to Clinical 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 (including translations, as applicable)
• Provides inputs to and/or develops study related materials such as Monitoring plans, recruitment plans and study Newsletters
• Supports/coordinates the negotiation of site budgets within Fair Market Value guideline, budget plans and provide oversight for site payments as per contract, as required.
• Participates 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, provides the leadership and clinical operations expertise for the local study team.

Internal Stakeholders

All Medical functions, Procurement, Legal, Finance

External Stakeholders

HCPs and HCOs, Regulatory authorities, Industry Bodies, Patient Support Groups and Vendors

Functional Competencies

Knowledge of ICH-GCP, Indian Regulations, multiple therapy area knowledge, technical expertise in the field of clinical operation, vendor management

Behavioral Competencies

Exhibition of Roche Core Values, Exhibition of Servant Leadership, Patient centricity in decision making, Strong Collaboration and Networking skills, Inspiring and Influencing

Eligibility Criteria (Qualification and Experience)

• University degree or equivalent; professional qualification preferably in a medical/science related field Pharmaceutical medicine training highly desirable
• Higher degree and / or specialist accreditation desirable
• Employee has completed minimum 1 year with Roche Pharma (Applicable for internal hire)
• Employee having an overall experience of minimum 5 years in Pharmaceutical / Biotech / Clinical Research industry with minimum 5 years in Clinical Operations.
• Clinical operations and quality assurance
• Job Location: Mumbai (HO)
• Willingness to relocate

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.