TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions.

Join Our Team as a Clinical Research Manager (CRM) - home based in Poland, Spain or Italy.

About this role

Key Responsibilities

• Manage day-to-day clinical operations activities for assigned projects in accordance with study protocols, contracts, SOPs, ICH-GCP guidelines, and applicable regulations.

• Serve as the primary sponsor contact for operational project-specific issues and study deliverables.

• Lead, coach, and support CRAs, ensuring project-specific training requirements are completed and documented.

• Oversee site quality and monitoring deliverables through direct supervision and guidance of study teams.

• Develop and implement study monitoring plans, site training plans, and verification initiatives.

• Coordinate investigator meetings and support site and country-level study reporting activities.

• Ensure study processes and operational strategies remain practical and effective from feasibility through study closeout.

• Act as the primary point of contact for CRAs and monitoring teams, providing guidance on site-related challenges and escalations.

• Support recruitment and monitoring strategies to optimize study performance.

• Conduct co-monitoring visits to ensure quality oversight and consistency across monitoring activities.

• Review and approve monitoring visit reports, ensuring timely resolution and escalation of identified issues.

• Review monitoring schedules and site visit calendars to ensure compliance with monitoring plans.

• Monitor protocol deviations, data listings, and quality metrics to proactively identify risks and implement mitigation strategies.

• Lead study team meetings and provide regular updates to Project Managers regarding site and country performance.

• Ensure accurate maintenance of study documentation and Trial Master File (TMF) quality, when delegated.

• Review CTMS data to ensure timely and accurate recording of country, site, and subject information.

• Support investigator payment tracking and approval processes when delegated.

• Collaborate with Project Managers on CRA onboarding, training, and handover activities.

• Contribute to study communications, newsletters, and operational updates.

• Provide project insights related to resource utilization, revenue recognition, and forecasting activities.

• Participate in Investigator Meetings and present monitoring requirements and expectations when required.

• Promote proactive issue resolution and a solution-oriented approach across study teams.

• Partner with CRA Line Managers regarding study assignments, workload planning, and performance discussions.

• Support business development initiatives, proposals, budget development, and bid defense activities as required.

Qualifications

• Bachelor's degree in Life Sciences, Clinical Research, Nursing, Pharmacy, or another health-related field.

• Minimum of 5 years of clinical research experience, including significant experience as a Clinical Research Associate (CRA) with independent on-site monitoring responsibilities.

• Minimum 1 year experience as an Unmasked CRA / CRM in an Ophthalmology study.

• Experience coordinating or overseeing clinical trial operations at a study, country, or regional level.

• Strong understanding of clinical trial processes from start-up through closeout.

• In-depth knowledge of Good Clinical Practice (ICH-GCP), regulatory requirements, and clinical research standards.
  
  For candidates based in Italy

  Salary: €63,000 – €65,000 gross/year, in line with CCNL Terziario-Servizi (Level III), plus benefits (lunch vouchers, health insurance, pension, and car allowance where applicable).
  

  We welcome applications from candidates belonging to protected categories under art. 1 L. 68/99.

What We Offer

A Bit More About Us

Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients' safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific, and the Middle East.