*6 month assignment with possibility to extend.

Job Summary:

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 deliverablesServes as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studiesOversees 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 Ethic Committees (ECs)Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to 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 mitigationMay be responsible and accountable for, as designated by the GSM:Regional, country and study level recruitment strategySupport of the development 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 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

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 teamsMay lead operational effectiveness initiatives at country or 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 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 systemsSupports 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 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 requirements

Skills

Expertise in the use of study and site dashboards and reporting toolsDetail oriented and possesses technical expertiseAbility to manage moderately complex processesRisk identification and mitigation, strategic planning, and critical path analysis skillsAnalytical and problem solving skillsAbility to adapt to changing technologies and processes, work independently and exercise own judgementSupportive of an environment where innovation is standard, including developing ideas and 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 operate in a matrix environmentFluency 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 meetings

Knowledge and Experience:

3-5 years clinical trial study management experience in CRO or pharma organization requiredComprehensive 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 othersComprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management teamWorking knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibilityDemonstrated clinical research experience and/or study management/startup project manager experienceDemonstrated experience in managing country level operational activities and/or vendors • Experience in study and quality managementKnowledge of clinical trial methodologyExperience working in a matrix management environmentRelevant operational clinical trial experience

Education:

Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial operations experience required OR Master’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

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.