Clinical Project Manager Study Maintenance

Clinical Project Manager Study Maintenance

The Almac Group provides world-class, integrated research, development and manufacturing services to over 600 companies in the pharmaceutical and biotechnology sectors. Almac has grown rapidly into a $600 million dollar plus organization with five individual, yet complementary divisions, offering a range of services.  The Almac Clinical Technologies division specializes in technology and service solutions that advance human health by increasing the quality and efficiency of the clinical trial process. Our technologies accelerate clinical trials, increase data quality, and decrease trial costs and our solutions have been used in over 1300 trials.
 

The Project Manager, Study Maintenance Level 1, has the following main areas of responsibility: 

• Assisting the Project Manager, Design & Implementation, during the start-up phase of a project by managing and completing several of the project set-up activities such as:
  • Assisting with user acceptance testing
  • Writing drug shipment details and managing drug release/labeling process 
  • Providing PS training and overseeing PS start up activities
  • Writing manual procedures 
• Performing project management responsibilities during the maintenance phase of a project such as:
  • Oversight of project quality
  • Oversight of project status and communication with client
  • Management of system change requests
  • Oversight of task completion by project team  
• Serving as the main client contact during the maintenance phase of the trial and delivery of excellent customer service.  Specific responsibilities include:
  • Meets Project Management Goals By:
    • Creating Manual Procedures
    • Reviewing and approving Daily Tasks
    • Overseeing the translation of the IXRS to ensure that they are completed with quality and on time
    • Overseeing the translation and distribution of site materials to ensure that they are completed with quality and on time
    • Reviewing Data Modifications
    • Providing support and oversight of assigned Project Specialist
    • Keeping study procedures/documents up to date  
    • Proactive management of study during the maintenance phase
  • Meets Department Goals By:
    • Assisting in project specific troubleshooting and problem solving
    • Assisting with after hours technical support for assigned studies
    • Reviewing technical support logs for trends and takes appropriate action
    • Participating in project specific sponsor teleconferences
    • Assisting with training of clinical study staff at investigator meetings when requested
  • Meets Company Goals By:
    • Providing oversight of project quality and excellent customer service during the trial phase
    • Ensuring project budget and recovery goals are met
    • Ensuring patient safety by delivering quality systems and service
  • Supports Administrative Goals By:
    • Maintaining timely client correspondence
    • Ensuring that all project documentation is maintained appropriately per working instructions 
• Maintains Quality Service by Following Organization Standards
• Maintains Technical Knowledge by Attending Educational Workshops and/or Reviewing Industry-Related Publications
• Completes Other Duties as Assigned by Management

• Bachelor degree - preferred (or)
  • Minimum of 2 years of college (actively working toward bachelor degree) with 2+ years of industry related experience - desired (or)
  • Associates Degree with 2+ years of industry related experience - required
• 18-24 months of supporting clinical studies utilizing IVRS technology or 1-2 years of pharmaceutical research or CRO industry experience
• Experience managing multiple projects simultaneously
• Minimum 2 years of client management experience
• Demonstrate knowledge of the clinical trial process
• Strong communication skills (written and verbal)
• Strong interpersonal skills
• Strong customer service skills
• Ability to operate in project team environment
• Strong organizational skills
• Ability to perform multiple project tasks
• Strong analytical skills
• Thorough working knowledge of Microsoft Word, Excel and Access