Clinical Projectmanager
Deze vacature staat offline! |
| The Company
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This organization is active in the nutrition branche. They sell products to over 80 countries worldwide. The organization develops high quality standard products and is constantly working to improve its products and create new products. The Clinical Projectmanager works in the Global R&D department, based in the Netherlands.
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| Description of the job
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The Clinical Project Manager is responsible for independently managing and overseeing all operational aspects of nutritional clinical trials. The incumbent will ensure that clinical trial data in support of regulatory submission and product messaging are of high quality and valid. Responsibilities will include, but will not be limited to:
- Participating in the design and development of clinical study protocols and Case Report Forms.
- Conducting investigator identification, selection, evaluation, initiation, and training.
- Managing protocol approval process, including IRB/Ethics Board submission and approvals.
- Managing contract clinical monitors to ensure monitoring efforts meet established timelines and deliverables.
- Developing and negotiating site budgets.
- Serving as the lead Sponsor contact for resolving site related issues.
- Managing projects by coordinating activities and organizational entities to keep projects on established timelines.
- Generating project documentation (including but not limited to) project specifications, project reports, communication records (logs), meeting agendas and minutes, and status reports.
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| Position Requirements and Necessary Skills
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- Thorough knowledge of ICH and GCP guidelines for clinical research.
- Ability to identify deviations from project plan and to work with project team and management to develop corrective action plans.
- Ability to work in a team environment.
- Ability to understand and review detailed clinical reports.
- Knowledge of project management tools and practices.
- Ability to manage multiple projects at varying stages of completion.
- Effective in setting and meeting personal short- and long-term goals to complete assignments.
- Ability to anticipate problems relating to projects and to develop and implement solutions.
- Excellent communication and organizational skills.
- Solid leadership skills.
- Strong MS Office skills.
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| Qualifications and Experience
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- BA/BS, preferably in a scientific field, or equivalent knowledge gained through experience working in a scientific area.
- At least 4 years of clinical research experience including field monitoring of clinical trials.
- Thorough understanding of traditional CRA skills (site identification, monitoring, tracking, data collection and cleaning).
- Practical experience of clinical trial methodology (study design).
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| Contactinformation
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Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Dr. Arjan van den Wijngaard
Consultant Medical
Biltstraat 443
3572 AW Utrecht
tel 030 231 7350
mobiel 06 50650550 |
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Geïnteresseerden kunnen hun c.v. ook rechtstreeks mailen naar arjan@pharmamediair.nl.
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