PRA Health Sciences

Clinical Site Operations Manager - Europe

Location
Europe, Remote
Salary
Competitive
Posted
02 Jun 2021
Closes
02 Jul 2021
Ref
TB2021-78517
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

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.

Typical responsibilities:

 

  • 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.

You are:

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

 

Apply for Clinical Site Operations Manager - Europe

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs