The Study Operations Manager I (SOM I) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on studies of limited complexity (a small number of countries/sites) or manages portions of a larger study (such as recruitment and retention).
Key Accountabilities:
Study Management Oversight:
• Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables
• Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies
• 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 Ethic Committees (ECs)
• Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to 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
• May be responsible and accountable for, as designated by the GSM:
o Regional, country and study level implementation of startup and site activation plans (through SUPM or pCRO if assigned)
o Regional, country and study level recruitment strategy o Support of the development of study level plans
o Communication with the local team and internal stakeholders and pCRO as applicable to ensure efficient and timely study delivery of the agreed plans
o Study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
o 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:
• May help guide the study management strategy by contributing local intelligence and providing accurate updates on delegated tasks to support establishment of critical path activities and risks
• May independently take on activities with instruction provided as needed
• 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 issue 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 (CTAs) and other roles as required
• Supports identification, contract development and management of local vendors or facilities as per protocol
• May lead and guide the closing out of one or more studies of low complexity 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 GCP standards, SOPs, local operating guidelines, and local regulatory requirements, as applicable
Subject Matter Expertise:
• Acts as the 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 and teams
• May lead operational effectiveness initiatives at country or regional level
• Utilizes roles in country such as Lead SCP, and expert roles such as Contracts Leads and SAPs, to provide the global teams with local intelligence and operational nuances to be considered
• Provides input on country level per subject costs, local vendor costs, and other fees where applicable
• Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan and Study Monitoring Plan, and ensures Trial Master File (TMF) completeness and oversight of all relevant compliance activities for allocated studies
• Supports implementation of client’s site technology experience systems
• Supports implementation of new tools and technologies (e.g., eConsent, eISF, remote source access, remote source data verification/review (SDV/SDR), iConnect, implementation of protocol required decentralized trial options)
Compliance with Parexel standards:
• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
• Expertise in the use of study and site dashboards and reporting tools
• Detail oriented and possesses technical expertise
• Ability to manage moderately complex processes
• Risk identification and mitigation, strategic planning, and critical path analysis skills
• Analytical and problem solving skills
• Ability to adapt to changing technologies and processes, work independently and exercise own judgement
• Supportive of an environment where innovation is standard, including developing ideas and taking appropriate risks to advance innovative processes
• Effective verbal and written communication skills in relating to colleagues and associates, both inside and outside of the organization
• Ability to operate in a matrix environment
• Fluency in written and spoken English required
• Ability to work outside of core business hours, as required, to support global trials or initiatives
• Ability to travel, as required, including Investigator Meetings, vendor kick off and re-set meetings, and client internal global or department level meetings
Knowledge and Experience (preferred):
• Comprehensive knowledge of own discipline with good knowledge of other disciplines to ensure that the study can meet its goals and to serve as a resource for others
• Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team
• Working knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibility
• 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
• Knowledge of clinical trial methodology
• Experience working in a matrix management environment
• Relevant operational clinical trial experience
o See below Education section for minimum requirements
Education:
• Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
• Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
• A scientific or technical degree is preferred
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