Project Manager – Country Study Manager

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

📋 Description

• Implementation of Startup and Site Activation Plans at the country/study level.

• Development of Recruitment Strategies at the country/study level.

• Assisting in the creation of study level plans.

• Engaging in communication with the local team, internal stakeholders, and CRO as necessary to ensure effective and timely delivery of the agreed study plans.

• Overseeing vendor management and coordination for study and/or country, including follow-up on vendor deliverables.

• Ensuring the follow-up and coordination of Regional/site QEs, PDs, data issues, metrics review, site issues/risks, audit responses, etc.

• Project Manager must operate independently and apply their own judgment.

• Managing and overseeing study and regional/country level activities from the startup phase through to execution and closure of the study.

• Potentially managing the study startup process in assigned countries and/or supervising the CRO responsible for these tasks.

• Supporting the Country/investigator outreach process, site identification, and feasibility through collaboration with the Site Care Partner/Country Trial Manager or CRO, ensuring compliance with all study protocol requirements.

• Providing country-level insights on Startup and Recruitment milestones.

• Accountable for supervising the CRO and/or Project Manager/Site Engagement Liaison 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).

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

• Ensuring adherence to relevant Global and Local, internal and external regulations and requirements.

• Facilitating timely bidirectional communication between the global and local study team.

• Offering protocol-level guidance and support to designated Local Study Team members as appropriate.

• Coordinating with the team to establish submission strategies for Health Authorities and Ethics Committees.

• Recognizing country-level trends to enhance deliverables processes as necessary.

• Ensuring readiness for audits/inspections during startup and execution phases.

• Guaranteeing that the CRO and/or relevant internal study team members manage appropriate levels of IP/equipment/ancillary supplies, including Import/Export License management, with assistance from Clinical Trial Assistants and other necessary roles.

⛳️ Requirements

• Bachelor’s or Master’s degree.

• A minimum of 2-3 years of experience in a similar role as a Local Trial Manager within a CRO or Pharmaceutical Industry.

• Familiarity with Good Clinical Practice and clinical and regulatory operations within the countries of responsibility.

• Proficiency in English is required.

🏝️ 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.