Associate Clinical Study Manager

“Bringing knowledge, experience and science together to discover, develop and deliver therapies for CNS disorders”

Are you a person who is a precise and enthusiastic team player? And do you have passion for contributing to the development of medicines for rare CNS disorders? Then this might be the perfect job for you!

VICO Therapeutics B.V. is a fast-growing Leiden-based biotech company with a focus on developing innovative antisense oligonucleotide therapies for rare neurological disorders.

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.

• Overseeing vendor-related study activities in collaboration with the CRO and vendor partners (e.g., central labs, analysis labs, imaging, distribution, concierge services).

• Alignment with the internal cross functional project team from VICO Therapeutics B.V., attending internal meetings.

What will you bring?

• 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.

What do we offer?

• 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

Where will you work?

We offer you the opportunity to contribute to the development of medicines for rare CNS disorders. Our small team is committed to bring new therapeutics to those patients who need it. The company atmosphere is pleasant and informal, contributing to a particularly friendly working environment.

Does this sound like the role for you? If so, we’d love to receive your application!