Responsibilities will include:
• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gain an in-depth understanding of the study protocol and related procedures.
• Perform remote and on-site monitoring & oversight activities
• Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and record clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• 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.
• Support and/or lead audit/inspection activities as needed.
• Extensive clinical monitoring experience
• Extensive knowledge of Good Clinical Practice/ICH Guidelines and other applicable
• Demonstrated proficiency in problem solving, juggling multiple priorities and a commitment to quality and customer focus
• Proven ability to work independently in a fast-paced environment
• Strong communication, interpersonal, and organizational skills. Mentoring capabilities
• Must demonstrate good computer skills
• Ability to provide clear direction and guidance to others
• Position requires approximately 60% travel (up to 80% during peak times)
• Fluency in Russian and a high level of English language are required
We have a comprehensive benefits package and offer highly competitive remuneration.
If you have the required experience for this position and are eligible to work in the required location then please apply by CV.
To find out more about our company and search and apply for other open jobs please visit our website [...] a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.
Primary Location: Europe - RUS-Client-Based
Job: Clinical Monitoring
Travel: Yes, 75 % of the Time
Employee Status: Regular