TFS HealthScience - Contract Research Organization एक वैश्विक कॉन्ट्रैक्ट रिसर्च ऑर्गनाइज़ेशन है, जो जैव-प्रौद्योगिकी और दवा कंपनियों को क्लिनिकल विकास के पूरे चरण में सहायता प्रदान करता है। इसकी सेवाओं में चरण I–III के परीक्षण, चरण IV के वास्तविक-विश्व साक्ष्य अध्ययन और रणनीतिक संसाधन उपलब्ध कराना शामिल है। कंपनी को त्वचाविज्ञान, आंतरिक चिकित्सा, तंत्रिका-विज्ञान, ऑन्कोलॉजी और हेमेटोलॉजी, नेत्र-विज्ञान, बाल-चिकित्सा, दुर्लभ रोगों और अनाथ दवाओं के क्षेत्रों में विशेषज्ञता हासिल है। यह एक पूर्ण-सेवा CRO की क्षमताओं और अंतरराष्ट्रीय पहुंच को मध्यम आकार के संगठन की लचीली तथा व्यक्तिगत सहयोगपूर्ण कार्यशैली के साथ जोड़ती है।
Senior Clinical Research Associate, Oncology - France Remote
Lead clinical trial site monitoring for oncology studies at TFS HealthScience, supporting participant safety, protocol compliance, data quality, and regulatory standards.
विवरण
- Support the Project Team in the operational delivery of clinical studies
- Initiate, monitor, and close clinical trial sites through on-site and remote visits
- Conduct trial monitoring in line with company and sponsor SOPs, GCP/ICH guidance, and applicable regulations
- Evaluate subject safety, data integrity, and study quality through monitoring activities
- Confirm proper informed consent processes and adherence to study protocols
- Review electronic or paper CRFs alongside source records
- Check the handling, reconciliation, and accountability of investigational products
- Prepare monitoring visit reports, record findings and corrective or preventive actions, maintain tracking systems, and escalate concerns
- Communicate identified issues and required follow-up actions to study sites
- Submit site documentation to the eTMF or paper TMF and confirm Investigator Site File maintenance
- Support preparation for audits and inspections and complete related follow-up
- Order, ship, and reconcile clinical study supplies when required
- Maintain accurate site information in CTMS and other project systems
- Work exclusively with one global pharmaceutical or biotechnology sponsor
आवश्यकताएँ
- Bachelor’s degree in life sciences or nursing preferred, or an equivalent qualification
- At least three years of oncology monitoring experience
- At least one year of experience in Phase I or II oncology studies
- Strong working knowledge of GCP and ICH standards
- Fluent English communication skills
- Comfort working in a fast-paced environment with shifting priorities
- Ability to work independently within a matrix team structure
- Strong written and verbal communication abilities
- Excellent organizational and coordination skills
- Confidence using technology, software, and computer systems
- Self-awareness, determination, flexibility, initiative, collaboration, analytical thinking, and close attention to detail
- Willingness and ability to travel up to 60–80%
लाभ
- Personal and professional development opportunities
- Purposeful and rewarding work environment
- Team culture centered on collaboration
- Strong focus on quality
- Opportunity to contribute to improved patient outcomes
- Flexible clinical development and strategic resourcing solutions