Clinical Research Manager

This is a fully remote position, open to applicants in Italy, +2 more states.

📋 Description

• Oversee daily clinical operations activities for designated projects in line with study protocols, contracts, SOPs, ICH-GCP guidelines, and relevant regulations.

• Act as the primary sponsor liaison for operational project-specific matters and study deliverables.

• Lead, mentor, and assist CRAs, ensuring the completion and documentation of project-specific training requirements.

• Supervise site quality and monitoring deliverables through direct oversight and guidance of study teams.

• Create and execute study monitoring plans, site training strategies, and verification initiatives.

• Organize investigator meetings and assist with site and country-level study reporting tasks.

• Ensure that study processes and operational strategies are practical and effective from feasibility to study closeout.

• Serve as the main point of contact for CRAs and monitoring teams, offering guidance on site-related issues and escalations.

• Support recruitment and monitoring strategies to enhance study performance.

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

• Review and authorize monitoring visit reports, ensuring prompt resolution and escalation of identified issues.

• Examine monitoring schedules and site visit calendars to ensure adherence to monitoring plans.

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

• Facilitate study team meetings and provide regular updates to Project Managers on site and country performance.

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

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

• Assist with investigator payment tracking and approval processes when assigned.

• Collaborate with Project Managers on CRA onboarding, training, and transition 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 as needed.

• Foster proactive issue resolution and a solution-oriented mindset across study teams.

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

• Assist with business development efforts, proposals, budget formulation, and bid defense activities as needed.

⛳️ Requirements

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

• At least 5 years of experience in clinical research.

• Substantial experience as a Clinical Research Associate (CRA) with independent on-site monitoring responsibilities.

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

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

• Strong comprehension of clinical trial processes from initiation through completion.

• Thorough knowledge of Good Clinical Practice (ICH-GCP), regulatory requirements, and clinical research standards.

• Candidates must reside in Poland, Spain, or Italy.

• For candidates based in Italy, applications are encouraged from individuals 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

• Chance to work on diverse and impactful clinical development programs

• Collaboration with talented colleagues globally