- a position that appeals to your communication skills;
- work in a small, professional and sociable organization;
- early phase studies with international contacts;
- a temporary assignment of 4-6 months.
Our relationship is based in Northeast of the Netherlands. The core business of this (international) organization is conducting drug research commissioned by international pharmaceutical and biotechnology companies.
At the clinic, our client is currently looking for a Clinical Project Manager Early Phase.
As Clinical Project Manager you are responsible for the preparation of the early phase clinical study, including costs and timelines and Set-up of a study. You provide timely notification of the study by the authorities such as EC and/or CA, and you take care of a timely and successful submission of studies to the EC and/or CA. Furthermore you are responsible for appropriate intervention in case of calamities on project performance (quality, budget, timelines) and you anticipate on regulatory changes. You ensure compliance of GCP and the quality system during a study. You perform a study according to the protocol, and you anticipate on deviations to the protocol and take care of the correct handling of deviations. You are responsible for reporting study status (to internal and external parties). Furthermore you are responsible for an optimal performance of the studies and where possible you optimize the study, for example reduction of costs and/or hours or optimize timelines.
You are responsible for the general organization of phase I and IIa studies in the clinical research center according to Good Clinical Practice (GCP), you coordinate all aspects of phase I and phase IIa studies, under which the preparation, recruitment and an effective deployment of personal and resources in the context of clinical studies. Of course you are responsible for the general organization and coordination of stand-alone consultancy, and other projects, when appointed to the Project Manager.
As the supervising Project Manager of an Associate Project Manager or the Clinical Trial Assistant, the Project Manager is final responsible for submission of studies to the EC and/or CA and you provide effective communication and maintaining a good relationship with the sponsor.
- the level of education for this function should be at least a Master Degree in Life Sciences
- the amount of relevant work experience for this function should be at least 4 years. Preference for (assistant) project leader or department manager in drug research
- specific skills for this function are experience in (project) management/policy/organization
- experience with phase 1 clinical research and experience wit customers from the United States
- good communication skills in English, Dutch is recommended
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/18-024-DD: email@example.com.
For further information, please call Mr. Toon Fleminks at number +31 (0)33 472 80 87.
Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.