Clinical Research Manager
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Job Description
Clinical Research Manager overseeing ophthalmology trials for TFS HealthScience, a global contract research organization. Coordinating CRAs, sites, sponsors, monitoring quality, and study delivery across Poland, Spain, and Italy.
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.
Requirements:
- Bachelor's degree in Life Sciences, Clinical Research, Nursing, Pharmacy, or another health-related field.
- Minimum of 5 years of clinical research experience.
- 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.
- Candidates must be located in Poland, Spain, or Italy.
- For Italy-based candidates, applications are welcomed from candidates belonging to protected categories under art. 1 L. 68/99.
Benefits:
- Competitive compensation package
- Lunch vouchers
- Health insurance
- Pension
- Car allowance where applicable
- Opportunity for personal and professional growth
- Opportunity to work on diverse and impactful clinical development programs
- Collaboration with talented colleagues across the globe
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