An opportunity has opened for a Snr Clinical Study Lead (Clinical Operations) to join a fantastic, medium sized pharmaceutical company based near Geneva, Switzerland on a permanent basis. You'll be joining this company at a significant time of growth where you'll be responsible and accountable for planning, coordinating, overseeing, and conducting complex global clinical trials in one or more therapeutic areas - whilst being responsible for the operations/ execution for their R&D sponsored clinical programs. Due to the success of our client's pipeline, there'll be clear opportunities for you to develop in your career here as you'll constantly be challenged so this would suit an individual who is looking to elevate their career within an established pharmaceutical company.
Reporting directly into the Director, Clinical Operations, this is an operations focus position with an element of strategic thinking involved, so my client is looking for someone with a strong pharma/ biotech background who is used to working in an outsourced environment whilst having a proven track record of the delivery of clinical studies. You'll also work collaboratively with your team members face-to-face, as you'll be required to come into the offices 2-3 times per week in Geneva, so you'll need to be flexible on this.
The role:
- The Study Lead is responsible and accountable for planning, coordinating, overseeing and conducting complex global clinical trials in one or more therapeutic areas.
- The Study Lead collaborates in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards, and services.
- The Study Lead is accountable to plan, drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations.
- Leads (multiple) cross-functional teams and drives oversight of CRO's and vendor management and has in-depth business knowledge and strategic understanding of how cross-functional teams jointly achieve objectives and goals of trial team, utilizing knowledge of the organization, processes, customers and key business drivers to increase effectiveness.
- Understands the different requirements of agencies related to the clinical packages and plans manages accordingly the different functions (ie CSR, TFLs, ISS etc)
- Accountable for inspection readiness
- Accountable for CAPAS related to clinical programs within the field of Clinical Operations
- Accountable and responsible for the financial planning, budget, accruals, Forecasts contribution
- Preparing clinical program updates and/or contribution to them as needed
Requirements:
- Advance degree in life sciences (graduate degree), e.g. Biology, Chemistry, Pharmaceuticals preferred or medical background
- At least 7 years' experience in clinical research in industry, and at least 5 years in clinical trial management
- Understanding GxP and global requirements
- Strong project management skillsets
- Excellent communication skills and ability to manage cross functional teams
- Ability to deal with complex situations and drive solution orientated thinking
- Fully fluent in English
- Excellent team player, ability to work under high pressure and pronounced resiliency
- Experience working in an international and cross-functional team
- Ability to present and defend the perspective
- Experienced in Microsoft project, Excel, Power point
What's on offer? A flexible basic salary, pension, relocation services, bonus, gym discount, travel allowance, lunch vouchers, insurance + much more!
If you are having difficulty in applying or if you have any questions, please contact Jack O'Neill at +44 203 8460 646.
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.
#LI-JO1
#Clinical
.png)
