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Supervisor Clinical Operations
2 weeks ago
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Clinical Operations Supervisor, Leeds
As one of the largest Clinical Research Organizations in the world, we have recently brought to life four ultramodern Clinical Research Units in the UK and USand the jewel in the crown is our facility at Drapers Yard Leeds. A brand new, world class, state-of-the-art 65,000 ft² clinic with 100 beds (and growing), fully dedicated to Phase I Clinical research (and 7 minutes walking from the train station)
We are looking for a Clinical Operations Supervisor to provide leadership, training, coaching and mentoring to our team of Clinical Research Nurses, and ensuring that all practical aspects of clinical studies are conducted to highest possible quality and in accordance with the study protocol, SOPs and ICH/GCP standards.
- This is a full-time, clinic-based job.
- 37 hours per week, predominantly Monday-Friday, but overtime and weekends may be required by the business as needed
WHO YOU ARE
The essence of this job is people management, this is why we need you to bring strong, large teams (10-15 members), supervisory experience in environments where this team has to deliver results within short cycles. By this we mean:
- Performance management,
- Individual & team training development,
- Ability to lead by example, gain process adherence from the team and encourage members to seek solutions.
- Holidays, absence, rota and shift organization.
- Bachelor's Degree in Life Sciences or Business
It´s ideal (not a must) if you bring:
- Current knowledge of ICH-GCP standards.
- Experience working in GCP, cGMP and/or GLP environments
A big PLUS: Six Sigma Green Belt
ON A NORMAL DAY, YOU WILL
Learn. And grow. No two days will be the same because you will be exposed to a wide variety of Therapeutic Indications and study types (single and multiple ascending dose, first-in-human, food effect, drug to drug interactions, radiolabelled human AME, etc.)
The core of your work will be supporting International Phase 1 clinical trials being conducted in the clinic. All our teams in Drapers Yard live to answer one question: is the drug safe? Under this framework, you will:
- Provide leadership, training, coaching and mentoring to a Nurse team so they deliver quality data on time, in strict accordance with relevant protocols, SOPs, and in compliance with ICH/GCP
- Build an impactful team: interview & hire new team members and nurture talent with full cycle performance management (managing KPIs, weekly 1:1s, performance discussions, development and career progression, discipline conversations when needed).
- Lead by example and actively support the culture and values of the Fortrea Clinical Research Unit at Drapers Yard.
- Craft new training plans, design training materials and delivery. Ensure that all team member training files are up to date and complete in accordance with SOPs and ICH/GCP
- Safety oversight and compliance. Ensure that a safe working environment is maintained in the Clinic, and that safe working practices are employed.
- Full oversight of on-site client audits
- Drive continuous improvement and best practices throughout the lab, identifying opportunities for process optimization and efficiency gains.
THERE IS ONE THING THAT ONLY FORTREA CAN OFFER
Under the same roof, we have: the clinic, a state-of-the-art processing laboratory and cutting-edge cGMP pharmacy and a state-of-the-art Lab. Supporting these functions we also have all elements of the full clinical Pharmacology Service including Data Management, Medical and Scientific, regulatory affairs, statistics and biometrics, all of which provides you with a hands on opportunity to develop your career within Fortrea.
You will witness firsthand the dosing and safety research as they are being conducted in real time. When the drug you worked with gets approved, you know you´ll touch many patient´s lives around the world.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, v
