The Country Study Operations Manager (cSOM) is responsible for regional/country level activities from study startup through conduct and study close.  The cSOM partners with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Site Care 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 cSOM 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. The cSOM ensures the operational delivery of responsible tasks within the assigned studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable.

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

• Regional/Country level implementation of Startup and Site Activation Plans

• Responsible for management/oversight of regional/country level activities from study startup through conduct and study close

• Responsible for 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.

• Leader of the Local Study Team (core members: Site Care Partners, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required)

• Is accountable for overseeing 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)

• Ensures timely communication bidirectionally between the global and local study team.

• Liaise with Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic Committees

• Ensures audit/Inspection readiness during start-up and conduct

• 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

• 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

• Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions

• Ensures 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

BASIC QUALIFICATIONS

• 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

• Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility

• English is required.

Prior 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

Skills and Technical Competencies

• Expertise in the use of study/site dashboard and reporting tools

• Detail oriented & possesses technical expertise

• Ability to manage moderately complex processes

• Ability to operate in a matrix environment

• Risk Identification & Mitigation

• Strategic Planning, Analytical and Problem-Solving Skills

• Critical Path Analysis

• Excellent communication skills, both written and verbal

• Ability to adapt to changing technologies and processes

• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

 
Work Location Assignment: Flexible