Clinical Start Up Manager
A leading and global clinical CRO is currently recruiting a Clinical Start Up Manager to join their team in Denmark. This organisation employs more than 700 professionals throughout 21 countries and currently delivers clinical research services in more than 40 countries. This is an exciting opportunity to bring expertise and skills to an established and in-demand company that specialises in Oncology, Immunology, Cardiology and Endocrinology.
- Accountable for project managing all trial start-up activities from protocol outline to the initiation of patient recruitment in phase II-IV.
- Ensuring that project key deliverables are met on time at a high quality by using your extensive operational trial management expertise, supported by the Trial Manager.
- Close collaboration with the Trial Project Manager whom is responsible for the project management and oversight of the end-to-end activities for the trial.
- Leading the protocol outline and protocol development with support from your colleagues working with medical writing, biostatistics, medical doctors etc.
- Leading the development of Patient Information/Informed Consent.
- Developing all documents, training materials and manuals for both clinical sites and for patients.
- Coordinating the development of documents for the Clinical Trial Application package, and managing questions received from Ethic committees.
- Managing stakeholders at all levels including clear communication on deliverables.
- Providing input to the setup of our clinical trial systems.
- Working closely with both internal and external stakeholders such as the Trial Project Manager, members from local affiliates and suppliers.
- Communicating with external vendors and be able to handle a variety of situations, e.g. take part in critical contract negotiations in case of escalations.
- Demonstrating digital skills and understanding of how to apply digital solutions into clinical trials.
- Keeping trial(s) moving forward, deftly navigating all bumps on the road to meet the deadlines and of course considering compliance in every aspect.
Skills and Responsibilities:
- MSc or BSc in Natural Science.
- 4 years of s relevant experience with trial management.
- Solid experience in managing start-up activities for global clinical trials.
- Comprehensive GCP knowledge, knowledge of clinical IT systems.
- High performer with a documented track record of experience.
- Excellent communication, presentation and negotiation skills.
- Create consensus across professional and geographical borders, build trust, establish mutually profitable working relationships.
- Fluent in written and verbal English.
- 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.
- Some travelling is expected.
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 Steven Fuller at +44 203 854 2630 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.