Clinical Study Manager vacatures in de branche Farmacie

Clinical Team Lead | Zeist

• Clinical Operations
• Full time
• Manager

is a therapeutically focused CRO, headquartered in Zeist, operating worldwide through our own entities and local partners.

We specialize in CNS, Cardiometabolic & Renal and Infectious Diseases, contributing to groundbreaking clinical research that advances global healthcare. We are currently recruiting for a Clinical Team Lead.

As a Clinical Team Lead , you will be responsible for the setup and oversight of clinical monitoring and site management activities across multiple countries. Your role includes training Clinical Research Associates (CRAs), ensuring adherence to protocols and regulatory standards, and managing vendor operations. You will play a key role in driving the success of clinical trials while maintaining high-quality standards and compliance.

Tasks and responsibilities

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.

Expected Outcomes

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.

Qualifications & Experience

• 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.

How to apply

Are you interested? Send your cv to .

If you have further questions you can contact Marjolijn Woudstra, Senior Recruitment Business Partner a.i via whatsapp: .

Our hiring process

Send your application to

Digital interview

You will receive an invitation for a digital meeting with the line manager and HR.

Interview at the office

You will receive an invitation for an interview at our office with your future colleagues.

Offer

If there is a match, you will receive an offer. Welcome aboard!

When. Trials. Matter.

The therapeutically specialized CRO