Your new company
Your new company is based in the Amsterdam area and is focused on making the future of medicine better using gene therapy. By doing so, they help patients with serious unfulfilled medical needs. This means that you will, indirectly, contribute to helping those patients and potentially giving them a better life. On a daily basis, you will contribute to this as well. The company is continuously looking for highly motivated and skilled people who are willing to make a difference.

Your new role
Responsibilities:

• Responsible for maintaining the study team roaster, informing internal & external team members of changes, and managing internal & external system access accordingly.
• Support the CTM with the creation and maintenance of the study-specific training matrix. Coordination and tracking of all study-level training for internal personnel as per the study-specific training matrix, as well as any other training provided to vendors and sites.
• Contribute to the oversight of vendors such as CROs and speciality labs.
• Support and oversight study start-up activities, including site-level documents collection, site budget and contracting.
• Support the set-up, tracking and managing of study logistics (i.e., lab samples reconciliation, system access, supplies, study document annual renewal dates, etc.) and supports other study administrative tasks as needed.
• Support the review and updates of clinical trials related SOPs and WIs and other process improvement initiatives.
• Trial Master File (TMF) subject matter expertise; Responsible for coordinating the internally facing TMF component set-up, maintenance, QC and close-out.
• Acts as a subject-matter expert in TMF Plan development/revisions.
• Responsible for providing (or facilitating) TMF training to and managing system access for document owners.

What you'll need to succeed

• Minimum of 5 years relevant work experience at a clinical site, CRO, Sponsor, or clinical-type vendor.
• Ability to interact with diverse internal and external stakeholders and navigate complex business environments.
• Ability to work with multiple project teams, prioritise tasks and effectively contribute to the project’s inspection readiness at all times.
• Demonstrates understanding of the end-to-end clinical trials set up for the assigned studies, including protocol objectives and operational impacts.
• Understanding of the responsibilities and needs of other functions in a clinical trial.
• Understanding of current ICH-GCP regulations and guidelines. Understanding of local or country-specific regulations.
• Computer skills: Intermediate level, recent and active knowledge of MS Office applications, able to support study or project documentation using core productivity software, and able to utilise core collaboration and clinical systems for trial/project purposes.
• Proficiency in English.

What you'll get in return
Hays Detachering | This is a project that will start with a contract for 12 months through Hays. Extension may be possible. In this position, you will get a salary of €58,000 and your travel expenses are covered. Please note sponsorship cannot be provided.

What you need to do now
If you are interested in this role as Senior Clinical Operations Project Specialist
Click ‘Apply now’ to send an up-to-date CV, or give us a call! Is this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion on your care.
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