Clinical Trial Monitor Freelancer

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to our constant growth, we are looking for a Clinical Trial Monitor to support our projects in Israel.

You will be responsible for:

Conduct remote/on-site monitoring visits to ensure compliance with study protocols, clinical monitoring plan, Good Clinical Practice (GCP), institutional policy, and other applicable regulations.

• Draft monitoring reports per trial's established needs and expectations.
• Perform source data verification (SDV) and review clinical documents for accuracy and completeness.
• Cross-functional collaboration including with data management, quality, regulatory, and clinical operations.
• Identify potential issues and risks and contribute to risk mitigation.
• Conduct training for contracted monitors, with support of other team members.
• Perform quality checks for contracted monitors.
• Conduct co-monitoring visits as a sponsor representative.
• Serve as a Subject Matter Expert for external monitors to consult with, with support of the internal team.
• For assigned sites and/or trials, provide guidance to sites for inspection-readiness aspects including protocol requirements; study procedures; data integrity; regulatory expectations; training; protocol deviations and Corrective and Preventive Action Plan implementation.
• Support site adherence with GCP and other applicable regulations
• Provide guidance on Investigator Site File and other relevant regulatory expectations, in line with NCI's NCTN mechanisms.
• Support data entry timeliness per Alliance policies
• Assist sites in addressing and resolving data discrepancies and other queries.
• Contribute to the development of the scope of work for monitoring services, and associated study plans, e.g., clinical monitoring plan.
• Adhere to the protocols' Clinical Monitoring Plan, e.g., monitoring visit type, frequency, and required critical monitoring activities.
• Coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for the completion of monitoring activities including submission of monitoring reports.
• Builds positive relationships with principal investigators and site personnel and actively participate with the study team to stay current with study needs.

About you:

• Bachelor's degree in relevant life science field
• +3 years of work experience in a similar role for a pharmaceutical company or related field.
• In-depth knowledge of GCP, ICH guidelines, and other applicable regulatory requirements.
• Proficient in navigating Electronic Medical Record systems.
• Proficient in using electronic data capture platforms and clinical trial management systems.
• Outstanding communication skills, both verbal and written.
• Proficient with Microsoft Office Word and Excel.
• Ability to work independently and prioritize duties.
• Availability to travel.
• Fluency in Hebrew and English.

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.