Senior Clinical Operations Manager
Supports Head Clinical Operations to manage function and people with insights and value creation within the team. Contributes towards shaping team culture and resources.
Has full accountability and oversight for all assigned studies at 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.
- 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.
- Provides operational oversight of Investigator-initiated Studies and Compassionate Use Programs in terms of Roche quality and safety standards, regulations, timelines and budget allocation.
- Coaches and provides support to responsible study team members.
- Provides study oversight, leadership and support to Contract Research Organization (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.
- Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.
- 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 COM acts as study leader and, in addition to the above, provides the leadership and clinical operations expertise for the local study team.
Local Vendor Manager
- Accountable for local oversight of the IQVIA FSP model- and other CROs where applicable, which perform activities under Roche sponsorship - to the quality, standards and competency level required.
- Ensures optimal performance and drives best practices, high performance and delivery; also provides proactive issue management and resolution through collaboration and effective partnership.
- Provides guidance to local study teams on ensuring IQVIA (and other CROs as required) are provided with relevant portfolio/study information and related projected country requirements to ensure study requirements are met effectively in terms of resources, competency, skills and experience.
- Leads all local partnership meetings with all vendors, to align and oversee goals, training and implementation of continuous improvement.
- In accordance with all applicable local employment laws, ensures there is effective two-way communication/feedback with vendors to support performance management discussions by responsible line managers.
- Seeks and measures internal and external stakeholder/customer satisfaction with local CRO service levels and implements appropriate escalation and resolution as needed.
- Identifies areas for continuous improvement within scope of vendor management and is responsible for rolling out related change management initiatives.
- Reviews, analyzes and reports Key Performance Indicators (KPIs) and performance metrics against benchmarks for local vendors and their staff, ensuring proactive problem solving and continuous improvement.
- Creates and maintains effective communication plans between Roche and local vendors at the local level. If working in a regional/subregional setting, is responsible for following the regional/subregional communication plan. Ensures information flows to/from internal stakeholders and appropriate vendors.
- Responsible for cascading and distributing information to internal Roche stakeholders and to appropriate vendors.
- Ensures effective resource management with the CRO counterpart, liaising with other CCO staff (Therapeutic Area Leaders, Resource Manager) as required.
- Implements and maintains accurate service agreements/contracts and budget information as it relates to local vendor management in collaboration with Procurement, Finance and other Roche stakeholders. Ensures local delivery is aligned with the global Master Service Agreements (where in place).
- Develops tools, processes and instructions for continuous improvement of vendor management locally.
- Trains local Roche staff on the principles and procedures governing collaboration with vendors.
- Ensures vendor oversight and performance in compliance with regulatory requirements and represents Roche in audit and inspection activities related to vendor management.
- Accountable for risk management, locally, of all vendors and vendor activities by close oversight and collaboration with internal and external stakeholders.
- Performing Vendor Oversight visits for ongoing assessments of vendors
- Performing resource management of resources working on IQVIA Roche FSP model
- University Degree or Equivalent preferably in a medical/science-related field.
- 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 9 years in Pharmaceutical / Biotech / Clinical Research industry with minimum 7 years in the Clinical Operations and Vendor Management.
- Job Location: Mumbai (HO)
- Willingness to travel domestically and internationally, as required
- Willingness to relocate
Roche is an equal opportunity employer.Medical Affairs, Medical Affairs > Medical Science Liaison