Beschreibung
Senior Clinical Trial Manager (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM+
Main tasks:
- Lead the overall initiation, coordination, implementation and management of large international Phase III clinical trials from start-up to close out
- Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met
- Manage operational and technical aspects of projects including budgeting, study initiation and risk management
- Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation
- Select, manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc
- Monitor vendor and CROs performance and ensure continuous oversight
- Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required
- Represent clinical operations on multi-function project teams internally and externally; report on study progress
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans
- Ensure the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company’s specific SOPs
- Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents
- Design, review and approve of all trial related documentation, and establish trial processes
Main qualifications
- University degree or equivalent in Life Sciences
- Fluent in English – French and another European language are an asset
- Large scale experience is critical
- Oncology experience is desirable
- Proven track record of successful management of large complex Phase III international clinical trials in the Pharmaceutical Industry or CRO, previous monitoring experience preferred
- In-depth knowledge and experience regarding the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems
- Experience in management of CROs, vendors and consultants, experience in external audits is an asset
- Strong project management skills
- Excellent budgeting, planning, and communication skills
- Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency
- Ability to lead and influence a cross-functional study team and external partners
- Former experience in contributing to protocols and clinical development plans
Main advantages:
- A highly motivated team and an open way of communication
- A very renowned company
- You will work in an international environment
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Dominic Yves Peter
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