Project Manager, Clinical Outcomes
Location – Warrington, PA
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 be responsible for 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
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
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.
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.
Clinical Project manager
Clinical - Operations
21/Aug/13, 4:57:01 AM
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