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Sr. Clinical Project Manager

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Location
MN
Job Type
Direct Hire
Date
Nov 27, 2018
Job ID
2642431

Our mid-sized client is growing and adding a Sr. Clinical Project Manager to the team!  Need to have written clinical protocol's independently and written a protocol from start to finish.  This person will be reporting to the Sr. Clinical Manager.


Your role with the company:
  • Development of clinical study protocols and ensuring clinical compliance in the conduct of clinical studies.                        
  • Reviews clinical data, provides direction on analysis of data, and develops clinical study reports with high attention to detail and accuracy.               
  • Manages and provides leadership for clinical personnel conducting clinical studies.                                                            
  • Coordinates activities with vendors and investigators to ensure compliance with protocol, regulations, Good Clinical Practices, company policies, and overall clinical objectives.                                                                                                 
  • Develops relationships with physicians and research personnel and travels to clinical sites to train or monitor clinical studies.                           
  • Facilitates or assists with meetings with health care professionals for Investigator Meetings, Data Safety and Monitoring Board, Clinical Events Committee, Advisory Boards, Steering Committees, and Publication Committees. Manages contracts with physicians and selection of committee members.                                                                                         
  • Develops clinical department metric tools and drafts work instructions, monitoring plans, data management plans and procedures to achieve and effectively maintain compliance.                                                                                                     
  • Responsible for overall study monitoring (review source documentation, case report forms, and data reports for accuracy and ensure the timely submission of such documentation) to assure compliance with the Investigational Plan, Monitoring Plan, and applicable regulatory guidelines and policies.                                                                                                         
  • Responsible for or assists with site identification, qualification, initiation, training, monitoring, and close out activities to ensure study compliance and subject protection.                                                                                                       
  • Responsible for accurate, complete and timely receipt of clinical data/information for completeness, oversees data correction and identifies adverse events.                                                                                                     
  • Knowledgeable of EU regulation and ability to facilitate international relationships pertaining to clinical studies conducted in Europe.
  • Tracks screenings & enrollment and identifies issues & addresses globally.
  • Communicates across departments and conduct project team meetings concerning status of the studies and specific sites.
  • Travel up to 25%.

Desired Profile:

  • A minimum of 5 years clinical research experience including monitoring activities required.
  • Bachelor degree or Nursing degree required

  Possesses working knowledge of clinical study regulations and Good Clinical Practices.                                                    

  • Exhibits strong leadership skills and the ability to manage clinical study teams and deliver on multiple clinical projects.     
  • Well organized, resourceful, effective and efficient at managing multiple projects while maintaining an ability to get things done.       
  • Displays understanding and application of electronic database principles and case report form design.                               
  • Possesses strong written and verbal communication skills; including the ability to communicate effectively to diverse audiences. Proficient with Clindex EDC and Microsoft Office Products (Word, Excel, PowerPoint)                                      
  • Competent speaking in front of others and conducting meetings with physicians, consultants, and clinical research organizations.                    
  • Demonstrated ability to identify study issues and implement solutions, including identifying and involving the appropriate decision makers. Ability to anticipate data needs and implement tools for effective study management.                          
  • Identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances.
  • Proficient knowledge of medical terminology. High attention to detail and accuracy. Willingness to accept challenging assignments and engage in relevant developmental activities.