Clinical Team Manager
- Experience Level
PRA and our employees have won numerous awards and accolades in the CRO industry and 2020 hasn’t been any different with gold winners in the Project Manager and Clinical Research Team of the Year at the Pharma Times awards!
We have won multiple awards across Europe, The America’s and Asia Pacific including BioPharma Asia/Phar-East Best CRO, Pharma Times Clinical Company of The Year and special recognition at the Vaccine Industry Excellent Awards.
We are currently looking for an experienced Clinical Team Manager (CTM) to be assigned to one of our sponsors, a Top 5 global pharma company.
The CTM is pivotal to trial delivery and compound development for the global R&D organization, providing leadership and driving decisions related to the conduct of a clinical trial. The CTM leads and manages the operational implementation of country feasibility, planning and delivery of R&D Phase I-IV clinical studies within and across therapeutic areas. The CTM serves as the operational point-of-contact between the Central Study Team and in-country staff aligned to the study. Accountable for high quality execution/delivery of studies within country as defined by the protocol & per agreed timelines / budget; overall project management of study activities.
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, the CTM's responsiblities include but are not limited to:
· 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)
· 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.
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
· Experience working in Vaccine clinical trials a plus
· Bachelor’s degree or Master’s degree or equivalent / PhD or MD
· Fluency in written and spoken English and Finnish
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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