Country Study Manager

2 weeks ago

Riyadh, Ar Riyāḑ, Saudi Arabia Genentech Full time

The Position:

Objectives and Scope of Position

  • The Clinical Operations Hub Country Study Manager (CSM) provides leadership and hub strategic planning and operational delivery of assigned clinical studies through all phases of study management (preparation, study startup, conduct, closeout), in accordance with Roche quality standards, all applicable regulations, timelines and budget commitments.
  • For Global/Regional Studies (referred as Global), the CSM leads and has full accountability (time, quality, cost) in alignment with the Study Management Team (SMT)
  • 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.

Role and Responsibilities

Main Responsibilities and Accountabilities

  • Has full accountability and oversight for all assigned studies at the hub 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.
  • Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.
  • Leads local study teams, represents hub 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.
  • May serve as global Country Study Representative (gCSR), as part of global study team.
  • 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.
  • Approves the validated clinical study documents which were translated from English into local language and /or back translated from local language into English.
  • 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.
  • Identify Principal Investigator and all other Sub-Investigators to be involved in the study.
  • For local studies, ensure publication within six months from the date the Clinical Study Report (CSR) was in place in accordance with Roche global publication policy.

Clinical Trials SPOC for the affiliate (Country SPOC)_ _

  • Country SPOC is the person nominated by the Head of ME Clinical Operations Hub who is responsible for providing requested quality or other data for particular country. Country SPOC could have different roles within the Hub structure; however should be knowledgeable about the respective country and most preferably located in that country.
  • Act as Single point of contact for consolidation of clinical operations inputs for all requests (for e.g. AMPs, ABPs, business reviews, data collection, etc) coming from different stakeholders at the country/affiliate level (for e.g. commercial, medical affairs, safety, regulatory, etc). All communication from Clinical Operations Hub side that are study specific should be handled by the CSM directly to the relevant stakeholder. All requests from the affiliate that are study specific, which the CSM does not know, should be sent to Country SPOC who should forward to the responsible CSM.
  • Act as representative of the Clinical Operations Hub in the Local Medical Compliance Office (LMCO) meetings conducted at the country/affiliate level. Country SPOC should attend and participate in such meetings.
  • Handle reactively requests from LQR and APT for consolidation of the country clinical operations data for the affiliate core compliance metrics and Affiliate Passport.
  • Communicate inputs from all CSMs working in the SPOC country on budget forecasts, budget deviations and budget updates during review rounds to relevant stakeholders. Country SPOC makes sure that Hub Head is fully aligned at all times. Country SPOC needs to be added in finance communication as the country contact.
  • Manage invoices before sending to the affiliate/country finance team (in case the CSS is not located in country) for the tasks

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