Senior Clinical Research Associate

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🇩🇰 Denmark – Remote

⏳ Contract/Temporary

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

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.

📋 Description

• Initiate, monitor on-site and/or remotely, and close out study sites during study conduct • 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 applicable regulations • Collaborate with study teams, investigative sites, and sponsors to ensure timely study deliverables, study blinding, and data quality • Monitor clinical trials according to company 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, and corrective/preventive actions; update tracking systems and escalate issues • Provide sites with identified issues and action items • Deliver site documents to the eTMF or paper TMF • Verify Investigator Site File maintenance • Update CTMS and other project systems with accurate site information • Participate in audit and 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 reviews, and CRA resource management • Perform Assessment Site Visits when requested • Mentor CRAs and develop therapeutic-area training • Participate in capabilities presentations

🎯 Requirements

• 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 • 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 the local language • Excellent organizational skills • Technology savvy with good software and computer skills • Ability to work in a fast-paced environment with changing priorities • Ability to manage complex or early phase studies • Willingness and ability to travel up to 60–80%, including overnight and international travel if applicable • Self-awareness, resoluteness, flexibility, collaborative mindset, proactivity, analytical approach, attention to detail, coachability, motivation, facilitation, and diplomacy • Ability to take ownership of assigned tasks

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Personal and professional growth opportunities • Collaborative and innovative work environment • Opportunity to make a difference in patients’ lives