Clinical Project Manager to Associate Director (remote-based)

Hobson Prior are looking for a Clinical Project Manager to Associate Director to join a fantastic biotech organisation on a permanent basis working remotely in Germany. Our client is focused on manufacturing ground-breaking therapeutics for cancer and other illnesses.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will be responsible for executing of cell and gene/individualised patient therapy clinical trials, mainly with regard to operational and administrative aspects.
• Support in planning consistent status reports to ADCO/SDCO and Chief Medical Officer (CMO), including presentation of project status in meetings.
• Monitor the clinical operation trial budget.
• Appropriate contact with PM and ADCO in case of deviations from the project plan.
• Supervisory on project timelines and deliverables.
• You will be forecasting and expecting prospects for practical problem-solving with a further concentration on cell and gene therapy necessities and requests such as variable dosing, out of specification IP, data collection specificities, patient planning logistics, process adaptation, etc.
• Arrange or oversight of study related documents such like Trial Management Plan, Monitor Manual, etc. with the ability to customise as per the needs of cell and gene therapy trials.
• Accountable for contributing to and examining study core documents, e.g. synopsis, investigator's brochure, patient informed consent documents etc. with and understanding of added cell and gene therapy needs (ex: redosing consents).
• Organisation of project pursuits with other internal departments or external vendors from start-up to close out of a clinical trial.
• Coach and oversee CTCs, CRAs and CTAs (in the scope of a project).
• Serve as the point of contact in case of problems within the clinical trial.
• Have responsibility over internal, external and cross-functional mediations for patient apheresis and treatment planning, prioritisation, logistics, etc.
• The ideal candidate will support in preparing and managing project training (including biomarker sample collection, etc.) prior to preliminary project activities, oversight and development of continual training needs and documentation.
• Cross-functionally communicate operational needs with particular attention to individualised patient therapy nuances.

Key Skills:

• Advanced conversational and correspondence skills, both written and spoken capabilities.
• Knowledge in usual software (Word, Excel, Power Point, MS Project).
• Ready to handle responsibility.
• Aptitude to swiftly enter into action and function under stress conditions with the ability to shift tactics, urgencies, and determined timelines.
• Experience working in a team as well as leading a team.
• Able to identify problems and offer resolutions, with attention on cell and gene therapy trial needs.
• Solid organisational skills.
• Strong communicative skills.
• You will have a proactive way of working, used to self-governing work.

Requirements:

• A background in natural / life sciences or medical (a university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant).
• Knowledgeable and highly experienced in pertinent legislation and international guidelines (ICH-GCP) for the performance of clinical research projects.
• At least 3 years of experience in project management, regulatory submissions, monitoring of clinical trials or clinical trial coordination with practice in project planning and structuring.
• Proficient in managing and problem-solving the complexities of cell and gene/individualised patient therapy clinical trial management.
• Well-spoken in the English language as well as great writing ability in the language.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.