Study Operations Manager Ii

The Study Operations Manager II (SOM II) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks.

**Study Management Oversight**
- Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies
- Provides back up to or assumes the responsibilities of the GSM as needed
- Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
- May manage the study start up process in countries assigned [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities as applicable
- Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs)
- Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to Global Study Manager (GSM) during planning
- Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Accountable for resolution of site activation escalations to study teams including offering options for mitigation
- Fully responsible and accountable for, as designated by the GSM:

- Regional, country, and study level implementation of startup and site activation plans (through SUPM or pCRO if assigned)
- Regional, country and study level recruitment strategy
- Development of study level plans
- Communication with the local team and internal stakeholders and pCRO as applicable to ensure efficient and timely study delivery of the agreed plans
- Study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
- Assurance of the follow up and coordination of regional and site quality events, protocol deviations, data issues, metrics review, site issues and risks, audit responses, etc.

**Study Management Operations**
- Executes tasks and develops solutions to problems as needed to support deliverables
- Manages and coordinates specific tasks and responsibilities as part of the larger study management team
- Through the SCP, CTM or pCRO, supports the country and investigator outreach process, site identification and feasibility ensuring countries and sites can meet all study protocol requirements
- 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
- Follows up on region and country level issues status to ensure resolution
- Identifies country level trends to improve deliverables processes as needed
- Ensures audit and inspection readiness during start up and conduct
- Manages applicable quality events with pCRO and local team as required
- Drives and ensures delivery of data cleaning deliverables for pCRO and sites as applicable
- Reviews Pre-Trial Assessment and Site Initiation Visit reports completed by SCPs
- Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets
- Drives pCRO and/or applicable internal study team members to ensure Trial Master File (TMF) set up meets study requirements, and maintains oversight of TMF completeness
- Ensures pCRO and/or applicable internal study team members maintain appropriate level Investigational Product (IP), equipment and ancillary supplies management including import/export license management with the support of Clinical Trial Assistants and other roles as required
- Supports identification, contract development and management of local vendors or facilities as per protocol
- May independently manage the closing of one or more studies post database lock
- Provides Investigator Meeting (IM) support and management, including conducting presentations as appropriate
- Provides country level documents to TMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions
- Provides support to ECs, Regulatory Authorities (RAs), and other relevant (e.g., radiation, biobank) submissions and deficiency and query responses for initial and subsequent Clinical Trial Application submissions within required timelines
- Ensures the operational delivery of responsible tasks in accordance with the appropriate quality standards including ICH G