Country Study Operations Manager - FSP

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The Country Study Operations Managers (cSOM) will have responsibilities for study and regional or specific country level activities from study startup through conduct and study close. The Study Operations Manager has responsibility for study management aspects of assigned studies of limited complexity (e.g. single country, a small number of countries/sites) or manage a unique part of a larger study (e.g. recruitment and retention). The Study Operations Manager will be assigned to one or more studies and will be tasked with taking on responsibilities in support of Global Study Managers, other Study Operational Managers and the larger Study Management delivery of the study. The Study Operations Manager may partner with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Country Trial Manager, Site Care Partners, Site Excellence Partners, Site Relationship Partners, Contracts Lead, Regulatory Affairs, pCRO and others as required to ensure a coordinated approach to study start up, execution and close out.

The cSOM has comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team. The Study Operations Manager I may lead specific parts of the project or drive specific countries. They may help guide the Study Management strategy by inputting local intelligence and providing accurate updates on tasks delegated to them in order to support establishment of critical path activities and risks. They will ensure the operational delivery of responsible tasks within one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable. The Study Operations Manager may be responsible to independently take on activities with instruction provided as needed. They may lead and guide the closing out of one or more studies of low complexity post database lock.

Responsibilities

Accountable for the execution of tasks of moderate complexity and developing solutions to problems as needed to support deliverables. The Study Operations Manager will be accountable and responsible for tasks as designated on the study by the Global Study Manager which may include:

• Regional/Country/Study level implementation of Startup and Site Activation Plans (through SUPM or pCRO if assigned)
• Regional/Country/Study level Recruitment Strategy
• Responsible to support the development of study level plans
• Communication with the local team and internal stakeholders and pCRO as applicable and as listed above to ensure efficient and timely study delivery of the agreed plans
• Responsible for study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
• Responsible for ensuring the follow up and coordination of Regional/site QEs, PDs, data issues, metrics review, site issues/risks, audit responses, etc.
• The Study Operational Manager will be able to work independently and exercise their own judgement.

ROLE RESPONSIBILITIES

Operational Study Management

• Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close
• May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable
• Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements
• Provides country level input on Startup and Recruitment milestones as provided by pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning
• Is accountable for overseeing pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans)
• Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation
• Leader of the Local Study Team (core members: (Lead) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required)
• Ensures compliance to relevant Global and Local, internal and external requirements and regulations
• Ensures timely communication bidirectionally between the global and local study team.
• Provides protocol level guidance and support to responsible Local Study Team members as applicable.
• Liaise with Site Care Partner, Lead Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic Committees
• Utilizes roles in country such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered
• Acts as the study level point of contact for all study[1]level questions for the Local Study Team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams
• Follows up on region/country level issue status to ensure resolution.
• Identifies country level trends to improve deliverables processes as needed
• Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies
• Ensures audit/Inspection readiness during start-up and conduct
• Manages applicable Quality Events with pCRO and local team as applicable and required
• Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets
• Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable
• Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable
• May act as a Subject Matter Expert
• May lead operational effectiveness initiatives at country or regional level
• Responsible for PTA and SIV report review for reports completed by the Site Care Partner
• Supports implementation of the sponsor's Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)
• Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CTA submissions within required timelines
• Drives pCRO and/or applicable internal study team members to ensure PTMF set up meets study requirements, and maintains oversight of PTMF completeness
• Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions
• Ensures pCRO and/or applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Assistants and other roles as required
• Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial options etc.)
• Support Identification, contract development and management of local vendors or facilities as per protocol
• Investigator Meeting support and management including doing presentations as appropriate
• Management of local Investigator Meetings including doing presentations as appropriate

BASIC QUALIFICATIONS

Training And Education

• Relevant operational clinical trial experience
• A scientific or technical degree is preferred along with knowledge of clinical trial methodology
• BA/BS 5+ years of relevant experience
• MBA/MS/ 3+ years of relevant experience
• BS/BSc/MS/MSc Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility English is required. Prior Experience Experience
• Demonstrated clinical research experience and/or study management/startup project manager experience
• Demonstrated experience in managing country level operational activities and/or vendors
• Experience in Study and Quality management and working in a matrix management environment