Associate Clinical Study Manager

Get 360Pharma; Leiden; Hybrid; EUR 55,000 - 69,000; Full time

Benefits offered by this job

Hybrid working options

32–40 hour work week

Pension scheme

28 vacation days

Travel allowance

Job summary

VICO Therapeutics B.V. seeks an Associate Clinical Study Manager to support international trials, collaborate with CROs, clinical scientists, and cross-functional teams to execute the first-in-human study of VO659 and future trials.

You will oversee study setup, patient monitoring, site feasibility, eTMF checks, vendor oversight, and alignment with the CSM/PM, with a focus on quality, regulatory compliance, and timely delivery.

Qualifications

• Bachelor and/or Master degree in life science or related scientific discipline.
• Experience 2 years in clinical trials (international) as a CRA.
• Fluent in English; Dutch is a plus.
• Experience in phase I/II trials.
• Thorough knowledge of legislation and ICH‑GCP guidelines.
• Strong communication skills, motivated and enthusiastic mindset, team-player attitude, attention to detail, and ability to maintain oversight of the bigger picture.
• Affinity with rare diseases.

Responsibilities

• Ensure operational excellence in the set-up and management of international clinical studies.
• Support the PM in all aspects of trial set-up and ongoing management.
• Perform oversight and co-monitoring visits in accordance with the PM.
• Support the conduct of site feasibility.
• Drive eTMF spot-check for the trial team and in collaboration with the CSM Review monitoring reports in alignment with the CSM.
• Attend and coordinate specialized training sessions with CRO (e.g., refresher trainings).
• Day-to-day alignment with the CSM and PM with regards to the activities of the CRO.
• Oversee vendor-related study activities in collaboration with the CRO and vendor partners (e.g., central labs, analysis labs, imaging, distribution, concierge services).
• Align with the internal cross functional project team from VICO Therapeutics B.V., attending internal meetings.

Skills

Fluent English

Dutch language

Strong communication

Team-player attitude

Education

Bachelor or Master in life sciences

Tools

Job description

Scope of Position

The Associate Clinical Study Manager (Associate CSM) will work with the Clinical Study Manager and Lead Clinical Project Manager at VICO Therapeutics B.V. in collaboration with the CRO, the Clinical Scientists and other Cross Functional Team members to execute upon the first-in-human study of VO659 and potential future clinical trials. The Associate CSM (together with the CSM) will report to the Project manager and will be the main VICO contact for the Clinical Trial Leads from the CRO and will be responsible for key aspects of study execution, as well as supporting broader activities across clinical operations and clinical science.

What will you do?

• Ensure operational excellence in the set-up and management of international clinical studies
• Support the PM in all aspects of trial set-up and ongoing management
• Performing oversight and co-monitoring visits in accordance with the PM
• Support the conduct of site feasibility
• Drive eTMF spot-check for the trial team and in collaboration with the CSM Review monitoring reports in alignment with the CSM
• Attend and coordinate specialized training sessions with CRO (e.g., refresher trainings)
• Day-to-day alignment with the CSM and PM with regards to the activities of the CRO
• Oversee vendor-related study activities in collaboration with the CRO and vendor partners (e.g., central labs, analysis labs, imaging, distribution, concierge services)
• Align with the internal cross functional project team from VICO Therapeutics B.V., attending internal meetings

Qualifications

• A Bachelor and/or Master degree in life science or related scientific discipline.
• Experience 2 years in clinical trials (international) as a CRA.
• You are able to speak and write fluently in English, Dutch is a plus.
• Experience working in phase I/II trials.
• Thorough knowledge of legislation and ICH‑GCP guidelines.
• Strong communication skills, a motivated and enthusiastic mindset, a team‑player attitude, attention to detail, and the ability to maintain oversight of the bigger picture.
• Affinity with rare diseases.

Benefits

• A gross annual salary between €55,000 and €68,700, including holiday allowance, depending on education and experience
• A working week of 32–40 hours
• An attractive pension scheme
• 28 vacation days, with the option to purchase additional days if desired
• Variable bonus, e.g., based on personal and company performance
• Hybrid working options, including a work-from-home allowance
• Travel allowance (€0.23 per km) or a NS business card
• Sports & wellness allowance
• A fun social calendar with team activities and office events