Senior Director, Clinical Operations
vor 3 Wochen
Proclinical Staffing are representing a trial blazing Biotech in Germany who are looking for a homebased Senior Director, Clinical Operations to join their team on a permanent basis. Being a medium sized company with over 3000 employees globally, our client is looking for an established Clinical Operations professional who has a proven track record within the oncology field who can lead operationally. Therefore, this opportunity will suit a professional who thrives in high performing environment within a Biotech environment who wishes to elevate their career.
**Your Main Responsibilities Are**
- Oversee activities related to the heading of the project teams, the supervision/ control of third party providers, the timely performance of all services, as well as stakeholder management of all departments involved.
- Oversee the development and review of portfolio documents such like Oversight Plans, Process Developments (including Trial RACI) and SOP development.
- Point of escalation in case of challenges in platform or vendor-related activities with other departments or external vendors; contributing to the process of selection and decision on participation of vendors, preferred vendors and partnership vendors.
- Taking care of team developments, identification of high-performance team members and working on team development.
- (Assurance of) Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions).
**What You Have To Offer**
- Natural/ life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant), combined with many years of experience in project management, regulatory submissions and global study organisations.
- CAR T cell experience is preferred.
- Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects.
- Profound experience with the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs.
- Excellent communication and ability to recognise problems and provide solutions.
- Able to rapidly enter in action and to work under stressful conditions.
- Able to motivate and lead a team.
What's on offer? A competitive basic salary + 20% bonus + much more.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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