Clinical Site Operations Manager - based in Europe
- Experience Level
Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop lifesaving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too. Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.
As Clinical Site Operations Manager you will be dedicated to one of our global clients, a global multi-product biotechnology company that develops and commercializes innovative antibody-based therapies for the treatment of cancer.
The Clinical Site Operations Manager will be responsible for coordination of all clinical operations site management and monitoring activities required to initiate, monitor and complete clinical programs at the clinical trial site level. May act as mentor for less senior members of the Clinical Trial Team and provides clinical operation input to the clinical project team.
- Act as Protocol Lead on one or more clinical trials.
- Participate as a member on assigned cross-functional study team and serve as the main point of contact for clinical site management and monitoring functions.
- Provide operational input to the key study documents including the protocol, informed consent, CRFs, Statistical Analysis Plan, and Clinical Study Report as assigned.
- Create and maintain clinical trial start up documents such as the Clinical Monitoring Plan.
- Participate in the identification, evaluation and selection of clinical trial investigators/sites.
- Manage clinical trial site monitoring team metrics.
- Provide support to field CRAs and may assist in the initiating and coordinating day-to-day operations of clinical trial sites.
- If any portion of the clinical monitoring function is conducted by a CRO, ensure performance meets expectations.
- Facilitate information flow between clinical trial sites, clinical project team members and other members of the clinical operations team, external CRO or contracted members, clinical field team, vendors, and other personnel as appropriate.
- Ensure completeness of clinical trial management system (CTMS) and Trial Master File (TMF) for assigned studies
- May assist in the preparation and follow-up of quality audits, as well as, regulatory authority inspections,
- Train, mentor, and may manage Clinical Research Associates (dotted line), in clinical trial management processes and all applicable regulations.
- Participate in development of department processes and best practices.
As a Clinical Site Operations Manager, you will have the opportunity to experience the full lifecycle of a project and genuinely contribute to drug development and improving patients’ lives.
Passionate and responsible.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- Strong interpersonal skills, organizational skills and ability to lead.
- Ability to manage multiple priorities simultaneously
- A quality-focused mindset
- At least 6 years of experience in Clinical Research, including 1 year in a similar role at a regional or global level
- Strong and recent experience working in oncology/ hematology clinical trials from phase I to III
- Bachelor’s degree or Master’s degree or equivalent / PhD or MD
- Fluency in written and spoken English
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
For more information please visit our website: www.prahs.com
*Note that we are flexible and consider different locations in Europe