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Trial Manager ED&CP *** Netherlands

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DOCS Global

2021-12-03 07:36:59

Job location Amsterdam, Noord-Holland, Netherlands

Job type: fulltime

Job industry: Science & Technology

Job description

Besides the LTM tasks, a TM may also be responsible for GTL and SM tasks depending on the studies assigned. For the GTL and SM tasks reference is made to the Job Description for the ED&CP GTL and SM and the GCO Procedural Documents.

•Collaborates with the FM for performing study feasibility and site assessments, providing recommendation of suitable sites for selection to participate in the trial according to ED&CP decision tree. Ensures appropriate follow-up of pre-trial visit activities. Collaborates with the GPL (Global Program leader), GTL, FM and other study team members to select final sites list.

•Contributes to the development of study management documents at a country level or initiates development of these documents for trials which follow ED&CP Hybrid Oversight Model.

•Leads and coordinates local trial team activities in compliance with GCO SOPs, other procedural documents and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget, including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting (if applicable).

Requirements:

•A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.

•Minimum two years of clinical trial management experience (in addition of site monitoring experience) is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.

•Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing in the Dutch and English language. Good written and oral communication skills.

Working at ICON is more than a job, it's a calling for people who care and are passionate about improving patients' lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.

It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.

At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.

Interested? Please send your CV to: Iris Brouwer ()

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