Clinical Project Manager
A leading clinical study organisation is partnering with ProClinical to recruit a Clinical Project Manager to join their German-based team. This is an exciting opportunity to work with a company that initiates and implements clinical studies that focus on cancer and tumour diseases.
- Provision of information for patients, clinics or practices ("study sites") interested in participating in studies/trials.
- Support of the study sites in (medical) content-related, methodological and organizational matters, e.g. inclusion/exclusion criteria for study participation; dose calculation; questions on the ethics committee, medical chambers, organizational procedures, etc.
- Preparation of study-specific documents and dispatch to the study sites.
- Processing of incoming documents, e.g. for registration and randomization of study participants, SAE notifications, investigator documents.
- Documentation of the data collected in studies (data input incl. encoding, plausibility check, corrections, consultation with dept. of statistics).
- Data processing after data input.
- Creation / processing of queries.
- Participation in the provision of study medication (in cooperation with competent departments of the respective pharmaceutical company).
- Registration and deregistration of investigators with the competent authorities.
- Communication with ethics committees, the Federal Institute for Drugs and Medical Devices (BfArM), authorities / institutions, German Hospital Federation (DKG), National Cancer Institute (NCI) etc.
- Coordination of communication between monitors, study sites, and/or the statistics department.
- Organization/cooperation in the billing/accounting of project-specific and other costs incurred.
- Participation in the organization and follow-up of study meetings.
- Participation in the preparation of new test protocols and case report forms.
- Participation in updating the SOPs.
- Participation in the preparation of publications and presentations of study results.
Skills and Requirements:
- A university degree from a relevant subject is desirable.
- Demonstrable experience in a similar capacity is desirable.
- Proficiency in English and German is desirable.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Reem Iskandaraniat +44 203 854 2629 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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