Job description
As a Clinical Operations Study Country Lead (COSCL), you will be the country-level operational lead in clinical studies. You will own and be accountable for the strategic planning, management, and performance of your assigned clinical trials within your country(ies) — from country allocation until study closure — at the Clinical Study Unit (CSU) level. You will oversee study timelines, country budgets, and conduct activities in accordance with ICH/GCP standards, internal operating procedures, and regulatory guidelines.
The COSCL acts as the key strategic interface with both global and local stakeholders to drive operational excellence and accelerate trial conduct.
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Your missions
* Set up local study country strategy and lead start-up activities
o Develop and implement early recruitment and retention strategies.
o Identify optimal site mapping and lead site engagement planning.
o Organize the local kick-off meeting and ensure project alignment with timelines.
* Lead local study management
o Own local performance of the study and ensure compliance with global and local plans.
o Drive project progress using risk assessment and mitigation strategies.
o Represent the CSU in study team meetings and escalate issues as needed.
* Manage study budget at country/cluster level
o Prepare and monitor country-level study budgets, ensuring cost optimization and financial accuracy.
o Proactively identify and escalate financial risks or variances.
* Coordinate communication and stakeholder alignment
o Act as the main link with local monitoring teams and ensure collaboration between internal stakeholders.
o Drive engagement initiatives such as recruitment booster calls and team meetings.
* Ensure quality and compliance
o Maintain data integrity, patient safety, and study compliance.
o Coordinate CRA training and collaborate on audits and inspections.
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Your profile
* Bachelor’s or Master’s degree in Nursing, Biochemistry, or related Natural Sciences.
* Proven experience in clinical research and project management, ideally with a background as a field monitor or site coordinator.
* Strong knowledge of the clinical development process and relevant therapeutic areas.
* Excellent project management, problem-solving, and risk management skills.
* Strong data analytics capabilities and proficiency in digital tools.
* Change management expertise and ability to work cross-functionally.
* Excellent communication and interpersonal skills with internal and external stakeholders.
* Fluency in English, French, and Dutch is required.
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What we offer
* Join a fast-growing organization that values innovation and continuous improvement.
* Work on high-impact, international projects in the life sciences sector.
* Benefit from career development programs and dedicated training paths through the Amaris Academy.
* Be part of an inclusive and multicultural team that fosters collaboration, intrapreneurship, and meritocracy.
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At Amaris Consulting, we are committed to fostering an inclusive environment where everyone feels respected and valued. We celebrate diversity in all its forms and strive to ensure equal opportunities for all employees, regardless of their background, identity, or experience.