Roche Pharmaceutical Science Manager Job Vacancy - Apply Online

Roche Pharmaceutical Science Manager Job Vacancy – Apply Online

Roche Hiring Pharmaceutical Science job opening 2022, Pharmaceutical science job vacancy. Clinical operations manager job opening 2022, Clinical operations job vacancy 2022. Pharmaceutical science job opening 2022. Pharmaceutical science job opening 2022. Check out all the details on the same below:

Job Title: Manager – Clinical Operations

Location: Mumbai

Eligibility Criteria & Experience:

● University degree or equivalent; professional qualification preferably in a medical/science-related field Pharmaceutical medicine training is highly desirable

● Higher degree and/or specialist accreditation is desirable

● Employee has completed a minimum 1 year with Roche Pharma (Applicable for internal hire)

● Employee having an overall experience of a minimum of 7 years in the Pharmaceutical / Biotech / Clinical Research industry with minimum of 5 years in Clinical Operations.

● clinical operations and quality assurance

Role Summary

Provides leadership to study team, 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.

How does the role serve the patients?

  • Provides hands-on experience to KOLs on new Innovative treatments by early participation in global trials.
  •  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 faster regulatory approvals for Roche Innovative products.
  •  Provide ongoing access to mature products through regulatory commitment studies.
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  • Has full accountability and oversight for all assigned studies at country level (Global, 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.
  •  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 global study team and CSM 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 develop and implements mitigation strategies as required.
  •  Coaches and provides support to responsible study team members by maintaining effective communication with CSM, and supports communication to local study teams, as required.
  •  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 (including translations, as applicable)
  •  Provides inputs to and/or develops study-related materials such as Monitoring plans, recruitment plans, and study Newsletters
  •  Supports/coordinate 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.
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