Clinical Team Lead | Zeist

Key Responsibilities

• Oversee clinical activities in assigned regions, ensuring adherence to predefined performance indicators for quality and efficiency.
• Ensure clinical trial execution aligns with protocols, SOPs, regulatory guidelines (ICH GCP E6), and local legislation.
• Act as a liaison between sponsors, Project Managers (PMs), and CRAs to facilitate clear and effective communication.
• Review monitoring visit reports and contribute to the development of project-specific documentation.
• Train CRAs on protocols, Case Report Forms (CRFs), and project-specific procedures, including conducting accompanied site visits.
• Organize investigator and CRA meetings to align study objectives and expectations.
• Ensure proper query resolution in collaboration with the Data Management (DM) team.
• Supervise and facilitate the reporting and follow-up of Adverse Events (AEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARs).
• Support CRA teams during inspections and audits conducted by healthcare authorities.
• Ensure proper documentation and archiving of project-related materials, both onsite and within the organization.
• Assist the PM in managing site management and monitoring budgets.
• Oversee vendor operations and manage relationships with local and consortium partners.
• Contribute to proposal development and participate in bid defense meetings.
• Conduct On-Site Compliance Checks and may lead Start-Up activities.

By excelling in this role, you will contribute to:

• • High levels of internal and external client satisfaction.
  • Well-trained and knowledgeable CRAs and local staff.
  • Adherence to project timelines and milestones.
  • High-quality clinical data and regulatory compliance.
  • Effective training programs and impactful accompanied site visits.
  • Strong vendor performance and operational efficiency.
  • Proactive risk identification and issue resolution for site and CRA management.
  • Successful execution of clinical projects within agreed scope, timelines, and quality standards.

• Higher level of education, preferably in a (bio)medical or related field.
• In-depth knowledge of ICH GCP E6 and relevant regulatory requirements.
• Strong proficiency in English (spoken and written).
• Experience in the pharmaceutical, biotech, or CRO industry.
• Minimum of 3 years as a CRA and at least 2-3 years as aCTL.
• Experience with independent monitoring of international multicentre industry-sponsored clinical trials.
• Prior experience in coaching and training CRAs is a strong advantage.

Are you interested? Send your cv to vacancies@juliusclinical.com.

If you have further questions you can contact Marjolijn Woudstra, Senior Recruitment Business Partner a.i via whatsapp: +31 6 28 25 65 82.