Operational Study Manager - Late Phase
- Experience Level
At PRA, we don’t make our 17000+ people great. It’s the other way around. As we have grown to a top-5 CRO, we have maintained the feel of a small company, dedicated to collaboration and passion for what we do.
We always have a desire to keep seeking new and better ways to operate. We don’t settle for the same old ways. Our passion for improving patient lives worldwide permeates all that we do. Put simply, we care.
Our industry-recognised Real World Solutions department focuses on peri- and post-approval ‘real world’ clinical research and is the ideal place for talented individuals with the right combination of experience and drive to forge a long-term career in an innovative and rewarding environment. Due to recent new business awards of exciting projects, the department would like to welcome on board a new Operational Study Manager.
The fundamental focus of your role will be to manage study teams on a variety of Real World Projects and achieve successful delivery of operational activities (site management, clinical monitoring and data review) by meeting internal and external client requirements.
Working on different global studies for the full project lifecycle, your key responsibilities will include:
- To manage all study site related activities
- To assume responsibility for project planning, set-up and conduct, communication and reporting and training of the study team
- To supervise the site recruitment and patient-enrolment stages of the study
- To liaise with the client for all site related issues, progress and risk
- To create study tools and dashboards (specifically related to study status and site performance), to create project documents and templates including training materials
- To plan on-site visits as required
- To lead the study team of Site Management Associates and Clinical Research Associates across a region
- To review and approve monitoring visit reports
- To manage the operational budget, identify out of scope tasks and escalate as required
- To manage and forecast resource needs to ensure project profitability
- To collaborate with colleagues in our Biometrics department for delivery of data management deliverables, to oversee the clinical data review process and ensure quality control steps are planned and completed.
Additionally, you may contribute to business development activities by participating in proposals and bid defences when required.
Depending on your experience and assignment, you may act as a global lead Operational Study Manager or even serve in a dual role incorporating project management responsibilities.
The working environment in this business unit is highly collaborative. This is in part thanks to our inspiring and friendly team of skilled colleagues who share a passion for real world research; a team that prides itself on fostering a human element within their work.
Location: The position can be home-based in Europe.
Passionate about real world studies, motivating and collaborative.
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:
- Prior clinical research experience, including site monitoring and management of study sites throughout the full project lifecycle
- Experience in motivating and leading global project teams
- A robust knowledge of real world clinical research, including study designs, GxP regulations and technologies / approaches associated with real world data capture.
- Knowledge of current post marketing regulations
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
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.