Country Study Operations Manager

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Accountable for the management and oversight of study and regional/country level activities from the initiation through execution and conclusion of studies.

• May oversee the study startup process in designated countries (when SUPM is not assigned) and/or supervise the pCRO responsible for these activities as necessary.

• Through the Site Care Partner/Country Trial Manager or pCRO, aids in the Country/investigator outreach process, site identification, and feasibility to ensure compliance with all study protocol requirements.

• Offers country-level input on Startup and Recruitment milestones as provided by the pCRO and/or Country Trial Manager/Site Care Partner to the Global Study Manager during planning phases.

• Responsible for overseeing the pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at the country level in alignment with the overall project plan, while managing and maintaining accurate country-level plans (e.g., timelines, budget, risk, and quality plans).

• Collaborates with responsible roles to identify and manage deviations and risks in study startup and execution, implementing necessary mitigation strategies.

• Also responsible for resolving Site Activation escalations to Study Teams, including presenting options for mitigation.

• Leads the Local Study Team (core members include (Lead) Site Care Partners, Clinical Trial Assistant, and ad hoc members such as ICL, Site Activation Partner, CTRO, Local Regulatory, Medical Affairs colleagues, and other key stakeholders as required).

• Ensures compliance with all relevant Global and Local, internal and external regulations and requirements.

• Facilitates timely bidirectional communication between the global and local study teams.

• Provides protocol-level guidance and support to the relevant Local Study Team members as applicable.

• Collaborates with Site Care Partner, Lead Site Care Partner, Site Activation Partners, and Regulatory colleagues in the country to establish submission strategies for Health Authorities and Ethics Committees.

• Utilizes roles in countries, such as Lead Site Care Partner, and expert positions like Contracts Leads and Site Activation Partners, to furnish the Global Teams with local intelligence and operational insights.

• Acts as the primary study-level contact for all inquiries related to the study for the Local Study Team, ensuring resolutions at the lowest possible level and liaising with and escalating issues to the appropriate global roles/teams when necessary.

• Monitors the status of region/country level issues to ensure timely resolutions.

• Identifies country-level trends to enhance deliverables processes as required.

• Leverages country intelligence to provide input on country-specific risks in the preparation of the Investigational Quality Management Plan and Study Monitoring Plans, ensuring the completeness of PTMF and overseeing all relevant compliance activities for assigned studies.

• Ensures audit/inspection readiness throughout the start-up and conduct phases.

• Manages relevant Quality Events with the pCRO and local team as necessary.

• Coordinates effective site recruitment planning to enable implementation of plans at the country and site levels, consistent with the global plan and local targets.

• Responsible for driving and ensuring the delivery of data cleaning deliverables for the pCRO and sites as applicable.

• Provides input on country-level per subject costs, local vendor costs, and other applicable fees.

• May serve as a Subject Matter Expert.

• May lead initiatives aimed at operational effectiveness at the country or regional level.

• Responsible for reviewing PTA and SIV reports completed by the Site Care Partner.

• Supports the implementation of client Site Technology Experience systems (e.g., Shared Investigator Platform SIP, Centralized Account Management CAM).

• Assists with submissions and deficiency/query responses to EC/RA and other relevant authorities (e.g., radiation, biobank) for initial and subsequent CTA submissions within required timelines.

• Drives the pCRO and/or applicable internal study team members to ensure that PTMF setup meets study requirements, maintaining oversight of PTMF completeness.

• Supplies country-level documents to PTMF and oversees the reconciliation and completeness actions of the Investigator Site File (ISF).

• Ensures that the pCRO and/or relevant internal study team members manage appropriate levels of IP/equipment/ancillary supplies, including Import/Export License management, with the support of Clinical Trial Assistants and other required roles.

• Aids in the implementation of new tools and technologies (e.g., eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, and implementation of protocol-required decentralized trial options).

• Supports the identification, contract development, and management of local vendors or facilities as per protocol.

• Provides support and management for Investigator Meetings, including making presentations as needed.

• Manages local Investigator Meetings, including delivering presentations when appropriate.

⛳️ Requirements

• A scientific or technical degree is preferred, along with knowledge of clinical trial methodology.

• A BS/BSc/MS/MSc degree is required.

• BA/BS with 5+ years of relevant operational clinical trial experience.

• MBA/MS with 3+ years of relevant operational clinical trial experience.

• Proficient understanding of Good Clinical Practice, as well as clinical and regulatory operations and environments in the countries under responsibility.

• Demonstrated clinical research experience and/or experience as a study management/startup project manager.

• Proven experience in managing country-level operational activities and/or vendors.

• Experience in study and quality management, as well as working in a matrix management environment.

• Expertise in utilizing study/site dashboard and reporting tools.

• Detail-oriented with strong technical expertise.

• Capable of managing moderately complex processes.

• Ability to operate effectively in a matrix environment.

• Skilled in risk identification and mitigation.

• Strong strategic planning, analytical, and problem-solving abilities.

• Proficient in critical path analysis.

• Excellent written and verbal communication skills.

• Adaptable to changing technologies and processes.

• Effective verbal and written communication capabilities when engaging with colleagues and associates.

🏝️ Benefits

• Competitive base salary and performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.