
501 - 1000 employees
Founded 2007
💼 Consulting
🏥 Healthcare
📦 Logistics
Consulting • Healthcare • Logistics
TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.
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501 - 1000 employees
Founded 2007
💼 Consulting
🏥 Healthcare
📦 Logistics
Consulting • Healthcare • Logistics
TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.
• Function operationally as a member of a Project Team • Initiate, monitor on-site and/or remotely, and close out clinical study sites • Provide unmasked Clinical Research Associate support for assigned clinical studies • Manage investigational product accountability and oversee unblinded site activities • Monitor protocol compliance in accordance with study requirements and regulations • Collaborate with study teams, investigative sites, and sponsors to ensure timely study deliverables, study blinding, and data quality • Monitor clinical trials according to TFS and/or sponsor SOPs, GCP, ICH guidelines, and applicable regulations • Perform monitoring activities to assess subject safety, data integrity, and quality • Verify informed consent procedures and protocol compliance • Review electronic or paper CRFs and source documentation for validity and accuracy • Report monitoring visit actions, findings, corrective and preventive actions, and update tracking systems • Provide sites with identified issues and required action items • Deliver site documents to eTMF or paper TMF • Verify Investigator Site File maintenance • Update CTMS and other project systems with accurate site-level information • Participate in audit or inspection preparation and follow-up • Order, ship, and reconcile clinical investigative supplies when applicable • Assist Clinical Research or Project Managers with project tracking, monitoring plans, report review, and CRA resource management • Perform Assessment Site Visits when requested • Mentor CRAs and develop therapeutic-area training when applicable • Participate in capabilities presentations when applicable
• Bachelor’s Degree, preferably in life science or nursing; or equivalent • More than 5 years of independent on-site monitoring experience • At least 1 year of experience as an unmasked monitor • At least 1 year of Ophthalmology experience preferred, ideally within a retina indication • Ability to work in a fast-paced environment with changing priorities • Understanding of basic medical terminology and science associated with assigned drugs and therapeutic areas • Understanding of Good Clinical Practice regulations and ICH guidelines • Ability to work independently and in a team matrix organization • Excellent written and verbal communication skills • Fluent in English and local language • Excellent organizational skills • Technology savvy with good software and computer skills • Self-awareness, resolute, flexibility, collaborative mindset, proactivity, analytical approach, attention to detail, coachability, motivation to take on new challenges, facilitation of discussion, and diplomacy in difficult situations • Ability to take ownership of assigned tasks • Ability to manage complex or early-phase studies • Ability and willingness to travel up to 60–80%, including overnight and abroad travel if applicable
• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaborative and innovative work environment • Opportunity to make a difference in patients’ lives
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