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Project Manager, Clinical Endpoints

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About the role

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Project Manager, Clinical Outcomes  

Location – Warrington, PA
 
Competitive Compensation
 
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The Project Manager will play a critical role within the Clinical Outcomes Department and oversee the delivery of projects in accordance with the contract, timelines and study budget. 
 
Overview of the Role
  • Identification and review of change orders for the budget
  • Attend and present at client Investigator, Kick-Off and client meetings
  • Ensure all necessary study specific training is provided to study team to improve performance and knowledge. Provide coaching / mentoring as necessary.
  • Management of  Electronic Case Report Forms (eCRF) development process
  • Development/ Review/ Maintenance of all trial documentation (Charter, eCRF, SRS, Reviewer Training Manuals)
  • User Acceptance Training and demonstration of eCRF
  • Data reconciliation
  • Primary client and CRO contact; develops successful working relationships with client / CRO
  • Preparation and management of meeting agendas and minutes
  • Prepare / Approve Project Reports
  • Management of Study Center(s)
  • Coordinates readers and review sessions
  • Conducts reader training with support of Project Director
  • Monitors Offsite Assessments/Blinded Reads
  • Quality Control of Offsite Assessments/Blinded Reads
  • Ensures all management/ tracking systems are up to date
  • Provide regular feedback to senior management on project status, client satisfaction and staffing issues.
  • Manages Data Management Lead for scheduling and preparation of data deliveries as required
  • Participate in Business Development activities as appropriate
  • Supports internal, client, and regulatory audits
  • Ability and willingness to travel
  • Participate in interview as required
  • Travel (approximately 35%) domestic and/or international
 
Role Requirements / Skills / Experience Required 
  • Experience in Cardio/Cardiac Imaging and/or Clinical Outcome trials a plus
  • Knowledge of GCP preferred
  • Ability to work as a team leader and  individually  on multiple client projects
  • Must have good documentation and organizational skills
  • Excellent communication and computer skills
  • Bachelor’s Degree or local equivalent in medicine or science
Benefits
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
 
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   
 
 
What’s Next
 
Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.
 
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
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