Study Operations Manager Ii
3 months ago
Job Summary
The Study Operations Manager is responsible for study and regional/country level activities from study startup through conduct and study close. The Study Operations Manager will be assigned one or more studies and will be tasked with taking on several responsibilities in support of the larger Study Management deliverables. The Study Operations Manager partners with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Country Trial Manager, Site Excellence Partners, Site Relationship Partners, 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 Study Operations Manager has exceptional knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team. The Study Operations Manager provides leadership and strategic planning and organization skills to ensure the operational delivery of 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 the closing out of one or more studies post database lock. Provides back up to or takes on the responsibilities of Global Study Manager as needed.
Accountable for the execution of tasks and developing solutions to problems as needed to support deliverables. The Study Operations Manager will be fully 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 for development of study level plans
- Communication with 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 and be a resource for others.
Job 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-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 reso
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