Senior Clinical Research Associate

About the role

You will drive the execution and oversight of clinical monitoring activities to safeguard data integrity and patient safety across assigned studies. You will act as a primary liaison between sponsors, investigative sites, and internal stakeholders to resolve queries and align on study progress. In this capacity, you will champion adherence to GCP, global regulatory standards, and WEP Clinical procedures in every interaction. You will leverage your expertise to identify and mitigate risks early, ensuring timelines are met without compromising quality. You will contribute to the continuous improvement of monitoring practices by applying lessons learned from each study cycle. You will mentor junior team members and foster a collaborative environment that values clarity, accountability, and shared learning. You will communicate complex information clearly to diverse audiences, translating regulatory requirements into actionable steps for sites and sponsors. You will take ownership of your portfolio, proactively managing priorities and adapting to evolving study demands with resilience and professionalism.

Key facts

What you'll do

Coordinate monitoring activities and compile monitoring reports to track site performance and data accuracy.

Perform on-site and remote monitoring visits to verify protocol compliance, source data accuracy, and patient safety documentation.

Ensure all case report forms are complete, consistent, and aligned with source documentation before database lock.

Engage with principal investigators and site staff to clarify discrepancies and implement corrective and preventive actions.

Review and interpret study protocols, amendments, and regulatory submissions to maintain up-to-date monitoring strategies.

Maintain detailed monitoring logs and timelines to ensure study milestones are tracked and met.

Facilitate the preparation of monitoring plans and other study-specific documents in collaboration with study leads.

Support the resolution of outstanding queries and deviations to keep data clean and analysis-ready.

Provide guidance and feedback to junior clinical research associates during monitoring activities and site visits.

Act as a key contact for sites and sponsors, addressing inquiries and managing expectations throughout the study lifecycle.

Champion the use of eClinical tools and systems to streamline monitoring workflows and enhance data oversight.

Identify trends in site performance and data quality to inform risk-based monitoring approaches and improve study execution.

Support the implementation of standard operating procedures and training initiatives to strengthen site compliance.

Proactively flag potential protocol deviations and ensure timely follow-up to protect data integrity and regulatory compliance.

Requirements

You hold a Bachelor's or Master's degree in Life Sciences, Pharmacy, Medicine, or a related scientific field.

You possess a minimum of 3 years of clinical research experience, with at least 1 year in a supervisory or mentoring role.

You have hands-on experience performing monitoring activities in accordance with GCP and ICH-GCP guidelines.

You are knowledgeable of global regulatory requirements and how they apply to clinical trials across multiple regions.

You demonstrate proficiency in using eClinical tools and databases for data review, query management, and reporting.

You have a strong understanding of source data verification and the ability to reconcile discrepancies efficiently.

You hold strong organizational skills, with the ability to manage multiple studies and prioritize tasks in a dynamic environment.

You communicate effectively, both in writing and verbally, with a high level of professionalism when interacting with sponsors and sites.

Nice to have

Experience with specific eClinical platforms is valued if previously used in clinical monitoring environments.

Familiarity with standard monitoring plans and risk-based monitoring methodologies is considered an advantage.

Background in therapeutic areas such as oncology, immunology, or rare diseases may support role effectiveness.

Experience coordinating training or leading junior team members in clinical research settings.

Practical notes

This is a remote position based in the Netherlands.

The role is full-time, requiring availability during standard business hours for collaboration with international stakeholders.

Travel may be required to support monitoring activities at investigator sites when necessary.

Candidates must be eligible to work in the Netherlands without sponsorship for this role.

Visa sponsorship is not available for this position.

Applications will be reviewed on a rolling basis, and early submission is encouraged due to the volume of applications received.