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Senior Clinical Research Specialist
hace 2 meses
Msd is seeking a highly skilled and experienced Senior Clinical Research Specialist to join our team. As a key member of our clinical research operations, you will be responsible for ensuring the successful execution of clinical trials in assigned countries.
Key Responsibilities- Ensure compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
- Develop and maintain strong site relationships and ensure continuity of site relationships throughout all phases of the trial.
- Perform clinical study site management/monitoring activities, including remote and on-site monitoring & oversight activities.
- Collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out.
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
- Identify, assess, and resolve site performance, quality, or compliance problems and escalate as necessary.
- Work in partnership with internal stakeholders, including GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, and regional operations, as well as external stakeholders, including vendors and IRB/IECs and Regulatory Authorities.
- Manage and maintain information and documentation in CTMS, eTMF, and various other systems as appropriate and per timelines.
- Contribute to CRA team knowledge by acting as a process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as necessary.
- Support and/or lead audit/inspection activities as needed.
- Strong understanding of ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Strong problem-solving and analytical skills.
- Ability to travel up to 75% of the time.
