Parexel

Country Study Operations Manager

Parexel

full-time

Posted on:

Origin:  • 🇳🇱 Netherlands

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Job Level

Mid-LevelSenior

Tech Stack

Google Cloud Platform

About the role

  • Oversees the 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
  • 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.
  • 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.
  • 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

Requirements

  • 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
  • Fluency in written and spoken English required
  • Demonstrated clinical research experience and/or study management/startup project manager experience
  • Experience working in a matrix management environment
  • Experience in managing country level operational activities and/or vendors
  • Knowledge of Good Clinical Practice, clinical and regulatory operations
  • Relevant operational clinical trial experience