Clinical Team Manager - Germany, Home based
- Experience Level
As a Clinical Team Manager you will be dedicated to a one of our global Biotechnology clients who have an emerging presence in Europe and who are committed to improving lives of patients though innovative and transformative therapies.
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.
Location: Germany, home-based.
The Clinical Trial Manager will be responsible for the execution of clinical trial site monitoring functions of a clinical trial, management of staff (direct or indirect) within the Clinical Trial Management Team, and development of standards and practices within the clinical trial management group.
. Acting as Protocol Lead on one or more clinical trials and serving as the main point of contact for clinical site management and clinical trial site monitoring functions
· Participating as a member on assigned cross functional study team
· Assisting with the design and review of study documents.
· Leading identification, evaluation and selection of clinical trial investigators/sites
· Managing clinical trial site monitoring team metrics to ensure performance maximizes efficiency, quality, ICH/GCP adherence, and meet clinical trial and corporate goals.
· Providing support to Field Clinical Research Associates (CRAs) and conducting monitoring visits including pre study, initiation, interim monitoring and close visits as needed.
· Coordinating and managing vendor processes for the clinical trial site monitoring function of clinical trials including central laboratories and Clinical Research Organizations (CRO).
· Ensuring completeness of Clinical Trial Management System (CTMS) and Trial Master File (TMF) for assigned studies.
· Performing performance evaluations and ensuring staff training is adequate and documentation of training is up to date.
· Assuming responsibility for development and maintenance of department SOPs or processes and ensuring assigned team adheres to them.
As a Clinical Trial 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
· 6 + years of experience in a similar role at a CRO or pharma company
· Strong experience working in oncology 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 is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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