Study Operations Manager II

Parexel FSP is looking for a Study Operations Manager II.

This is a remote position in Canada.

Job Purpose: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.

Key Accountabilities:Supporting Activities may include but not limited to the following:

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/orCountry Trial Manager (CTM)/Site Care Partner (SCP) for assigned studiesat 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 theStart 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 regulatorycolleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs)• Provides country level input on startup and recruitment milestones asprovided by pCRO and/or CTM/SCP to Global Study Manager (GSM) during planning• Collaborates with accountable roles to identify and manage deviations andrisks in study startup and execution and implements mitigation strategies asrequired. 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:o Regional, country, and study level implementation of startup and siteactivation plans (through SUPM or pCRO if assigned)o Regional, country and study level recruitment strategyo Development of study level plans

o Communication with the local team and internal stakeholders andpCRO as applicable to ensure efficient and timely study delivery ofthe agreed planso Study and/or country vendor management and oversight includingfollow up and coordination of vendor deliverableso Assurance of the follow up and coordination of regional and sitequality events, protocol deviations, data issues, metrics review, siteissues and risks, audit responses, etc.

Study Management Operations• Executes tasks and develops solutions to problems as needed to supportdeliverables• Manages and coordinates specific tasks and responsibilities as part of thelarger study management team• Through the SCP, CTM or pCRO, supports the country and investigatoroutreach process, site identification and feasibility ensuring countries andsites can meet all study protocol requirements• Ensures compliance to relevant global and local, internal and externalrequirements and regulations• Ensures timely communication bidirectionally between the global and localstudy 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 andsites as applicable• Reviews Pre-Trial Assessment and Site Initiation Visit reports completed bySCPs• Coordinates effective site recruitment planning to allow for implementation ofplans at the country and site level, consistent with global plan and localtargets• Drives pCRO and/or applicable internal study team members to ensure TrialMaster File (TMF) set up meets study requirements, and maintains oversightof TMF completeness• Ensures pCRO and/or applicable internal study team members maintainappropriate level Investigational Product (IP), equipment and ancillarysupplies 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 localvendors or facilities as per protocol• May independently manage the closing of one or more studies postdatabase lock• Provides Investigator Meeting (IM) support and management, includingconducting presentations as appropriate• Provides country level documents to TMF and maintains oversight ofInvestigator 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 responsesfor initial and subsequent Clinical Trial Application submissions within required timelines

• Ensures the operational delivery of responsible tasks in accordance with theappropriate quality standards including ICH GCP standards, SOPs, localoperating guidelines, and local regulatory requirements, as applicable

Subject Matter Expertise• Acts as the study level point of contact for all study level questions for thelocal study team, ensuring resolution at lowest possible level, and whenneeded liaising with and escalating to appropriate global roles and teams• May lead operational effectiveness initiatives at the regional level• Utilizes roles in country such as Lead SCP, and expert roles such ascontracts 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, andother fees where applicable• Utilizes country intelligence to provide input on country specific risks intopreparation of Investigational Quality Management Plan and StudyMonitoring Plans, and ensures 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 verifications/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 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• Ability to create an environment where innovation is standard, including taking appropriate risks toadvance innovative processes• Effective verbal and written communication skills in relating to colleagues and associates, both insideand outside of the organization• Ability to apply exceptional knowledge of own discipline and advanced knowledge of others to ensurethat a Sub Business Unit/Sub Operating Unit meets its goals• Ability to develop ideas and lead complex projects across a Sub Business Unit/Sub Operating Unit• Ability to develop innovative solutions to complex problems impacting a Sub Business Unit/SubOperating Unit• Ability to work independently with assignments, often self-initiated, and to exercise own judgment• Ability to manage in a matrix environment and to be a resource for others• 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, andclient internal global or department level meetings

Knowledge and Experience:• Knowledge of site selection, site activation, and site readiness interdependencies as well as clinicaltrial methodology and the drug development process• Exceptional knowledge in managing and coordinating specific tasks and responsibilities as part of thelarger study management team• Working knowledge of Good Clinical Practice, clinical and regulatory operations, and environment incountries under responsibility• Extensive operational clinical trial experienceo See below Education section for minimum requirements• Experience in clinical research and/or study management/startup project manager experience• Knowledge of clinical trial methodology• Experience participating on cross functional teams and working in a matrix management environment • Project management and quality management experience

Education:• Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operationalclinical trial experience required• Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevantoperational clinical trial experience required• A scientific or technical degree is preferred