ICON Clinical Research Project Manager, CEC in North Wales, Pennsylvania
Project Manager, Clinical Outcomes
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. This person is responsible for managing client studies within Clinical Outcomes.
Overview of the Role*
Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
Manage project in a timely manner in adherence with ICON’s SOP’s, ICH, GCP and appropriate regulation and liaise with other department managers as necessary.
Delivery of projects in accordance with the contract, timelines and study budget*
Identification and review of change orders for the budget
Attend and present at client Investigator, Kick-Off and client meetings*
Co-Development MIRA Project Set-up*
Ensure all necessary study specific training is provided to study team to improve performance and knowledge. Provide coaching / mentoring as necessary.
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
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.*
Participate in BD 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*
Other duties as assigned
Oversight of study*
Management of Study Centers
Manages Data Management Lead for scheduling and preparation of data deliveries as required
Management of eCRF development process*
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
US/LATAM/CAN: a minimum of 2 years’ experience in clinical trials
EU/APAC: prior relevant experience in clinical trials
Good commercial awareness and customer focus
Background in clinical trials
Trained in Good Clinical Practices
Able to work as team leader and individually on multiple client projects
Good understanding of Project Management processes
Highly developed problem solving skills
Strong people management and effective communication skills
Ability to multi-task
Business Computer skills
Good commercial awareness and customer focus
Due to the nature of this position, it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid driver’s license.
Bachelors Degree or local equivalent in medicine or science
Certified in Imaging Sciences or local equivalent degree / experience
Fluent in written and spoken English. Additional language skills desirable.
Benefits of Working in ICON*
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 you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
- ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.*