Clinical Research Manager

TFS HealthScience

5d•Remote

About The Position

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. At TFS HealthScience, you will be part of a global team dedicated to advancing innovative therapies and improving patient outcomes. We are looking for an experienced Clinical Research Manager (CRM) to join our Ophthalmology team and play a key role in overseeing clinical trial operations across multiple studies and countries. This is a full-time, home-based opportunity open to candidates located in Poland, Spain, or Italy. As part of our Ophthalmology team, you will work alongside passionate and innovative professionals to ensure our customers achieve their clinical development goals. The Clinical Research Manager (CRM) will be responsible for coordinating and overseeing country and site management activities during study conduct in compliance with company policies, SOPs, ICH-GCP guidelines, regulatory requirements, and contractual obligations. You will work closely with Project Managers, Clinical Research Associates (CRAs), sponsors, and investigative sites to ensure studies are delivered on time, within scope, and to the highest quality standards.

Requirements

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.

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.