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Clinical Project Manager (Remote) - United States  

Company managed [?] Still accepting applications
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Posted on : 20 May 2017

Project Description

Company Profile:  
  • Our company  is the leading global provider of outsourced clinical research services.  
  • Customers include the leading global pharmaceutical companies as well as biotechnology and small to mid-sized pharmaceutical companies.  
  • Our focus is on the development of innovative pharmaceuticals with the goal of enabling companies to reach early decisions concerning which compounds to progress further into clinical development.  
  • Supporting our clinical work are two world class bio-analytical laboratories located in Europe and the U.S.  
  • Our company  is unique from other leading CROs in that our focus is on early phase clinical studies through clinical proof-of-concept, and beyond.

Services Include:   
  • Early Clinical Research and studies required to support product labeling 
  • Data Management and Biometrics (modeling and simulation, study design and protocol development, clinical data management, biostatistics, PK/PD,  medical writing and reporting) 
  • Bioanalytical Services (discovery to late stage services with capabilities in small and large drug, metabolite and biomarker molecules) 
  • Drug Development Services (Regulatory affairs and drug development consultancy) 
  • Global Clinical Development including project management and monitoring 

Position Summary:
  • Our company  is looking for a Clinical Project Manager who will be responsible for the independent management of multi-center site activities ensuring compliance to protocol, ICH Good Clinical Practices, Standard Operating Procedures and regulatory and local requirements.
  •  This role will be home based anywhere in the United States.  Due to our international footprint, schedule flexibility is important. 
  • This position will travel roughly 30% primarily in the US, but could include Europe on an as needed basis.

Essential Responsibilities:     
  • Lead the initiation, maintenance and close out activities of multi-center studies in accordance with the protocol, GCP, and relevant SOPs 
  • Support the evaluation of suitability of site personnel and facility for initial and ongoing conduct of clinical trial 
  • Verify the accuracy and integrity of study data through collaboraton with data management 
  • Monitor screening and recruitment activities, assist site personnel with strategies to ensure enrollment is on target 
  • Participate in development of study plans such as monitoring, data management and safety plans 
  • Coordinate activities with central laboratories and other external service providers 
  • Update and review of clinical trial management tracking systems (CTMS) 
  • Review budgets and contracts 
  • Maintain appropriate and effective communication with sponsor and other internal departments to ensure successful project completion 

Qualification and Skills Requirements: 
  • Bachelor's degree required, preferably in science, nursing, other biomedical discipline, or equivalent 
  • Seven to ten years clinical research experience as a CRA or equivalent, such as research coordinator with minimum of 3 years of direct clinical project management experience 
  • Experience in support of business development processes; including budgets, proposals and bid defense planning and execution 
  • Ability to work across multiple projects 
  • Flexible and willing to travel up to 30% (regional) 
  • Excellent problem-solving and decision making skills   
  • our company  is an equal opportunity employer.