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Study Operations Manager II

3 months ago


Toronto, Ontario, Canada Parexel Full time

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 studiesProvides back up to or assumes the responsibilities of the GSM as neededOversees 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 applicableLiaises 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 planningCollaborates 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 mitigationFully 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 strategyDevelopment of study level plansCommunication with the local team and internal stakeholders and pCRO as applicable to ensure efficient and timely study delivery of the agreed plansStudy and/or country vendor management and oversight including follow up and coordination of vendor deliverablesAssurance 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 OperationsExecutes tasks and develops solutions to problems as needed to support deliverablesManages and coordinates specific tasks and responsibilities as part of the larger study management teamThrough 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 requirementsEnsures compliance to relevant global and local, internal and external requirements and regulationsEnsures timely communication bidirectionally between the global and local study team. Provides protocol level guidance and support to responsible local study team members as applicableFollows up on region and country level issues status to ensure resolutionIdentifies country level trends to improve deliverables processes as neededEnsures audit and inspection readiness during start up and conductManages applicable quality events with pCRO and local team as requiredDrives and ensures delivery of data cleaning deliverables for pCRO and sites as applicableReviews Pre-Trial Assessment and Site Initiation Visit reports completed by SCPsCoordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targetsDrives pCRO and/or applicable internal study team members to ensure Trial Master File (TMF) set up meets study requirements, and maintains oversight of TMF completenessEnsures 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 requiredSupports identification, contract development and management of local vendors or facilities as per protocolMay independently manage the closing of one or more studies post database lockProvides Investigator Meeting (IM) support and management, including conducting presentations as appropriateProvides country level documents to TMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actionsProvides 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 timelinesEnsures 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 applicableSubject Matter ExpertiseActs 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 and teamsMay lead operational effectiveness initiatives at the regional levelUtilizes 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 consideredProvides input on country level per subject costs, local vendor costs, and other fees where applicableUtilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan and Study Monitoring Plans, and ensures TMF completeness and oversight of all relevant compliance activities for allocated studiesSupports implementation of client's site technology experience systemsSupports 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 StandardsComplies with required training curriculumCompletes timesheets accurately as requiredSubmits expense reports as requiredUpdates CV as requiredMaintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirementsSkills:Expertise in the use of study and site dashboards and reporting toolsDetail oriented and possesses technical expertiseAbility to manage complex processesRisk identification and mitigation, strategic planning, and critical path analysis skillsAnalytical and problem solving skillsAbility to adapt to changing technologies and processesAbility to create an environment where innovation is standard, including taking appropriate risks to advance innovative processesEffective verbal and written communication skills in relating to colleagues and associates, both inside and outside of the organizationAbility to apply exceptional knowledge of own discipline and advanced knowledge of others to ensure that a Sub Business Unit/Sub Operating Unit meets its goalsAbility to develop ideas and lead complex projects across a Sub Business Unit/Sub Operating UnitAbility to develop innovative solutions to complex problems impacting a Sub Business Unit/Sub Operating UnitAbility to work independently with assignments, often self-initiated, and to exercise own judgmentAbility to manage in a matrix environment and to be a resource for othersFluency in written and spoken English requiredAbility to work outside of core business hours, as required, to support global trials or initiativesAbility to travel, as required, including Investigator Meetings, vendor kick off and re-set meetings, and client internal global or department level meetingsKnowledge and Experience:Knowledge of site selection, site activation, and site readiness interdependencies as well as clinical trial methodology and the drug development processExceptional knowledge in managing and coordinating specific tasks and responsibilities as part of the larger study management teamWorking knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibilityExtensive operational clinical trial experienceSee below Education section for minimum requirementsExperience in clinical research and/or study management/startup project manager experienceKnowledge of clinical trial methodologyExperience participating on cross functional teams and working in a matrix management environmentProject management and quality management experienceEducation:Bachelor's of Science or Bachelor's of Arts degree with a minimum 7 years of relevant operational clinical trial experience requiredMaster's of Science or Master's of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience requiredA scientific or technical degree is preferred #LI-REMOTE