Independent Committee Project Leader - DSMB/DMC
Parexel International Corporation
Parexel's growth continues into 2021!
Great opportunity to join Parexel’s best in class Global Medical Sciences Team as an Independent Committee Project Leader as we continue to expand the Team! This role offers the flexibility to work alongside our highly talented team in our HQ2 in Durham (when the office safely reopens) or from your home in the US! This highly visible role combines your PV experience with your excellent project management expertise and also draws upon your incredible attention to detail and outstanding communication skills!
As an Independent Committee Project Leader (ICPL) at Parexel, you will be welcomed into a great team with a highly supportive Manager and work alongside a highly experienced and tenured team! You will work closely with Medical and Statistical experts and gain exposure to incredibly fascinating study related safety and efficacy discussions in a broad range of therapeutic areas.
As an ICPL, you will support and manage Data Safety Monitoring Boards (DSMBs)/Data Monitoring Committees (DMCs) as part of full-service programs, and act as Project Leader of DMC/DSMBs for standalone programs.
The position includes both operational and financial management which includes: Serving as the initiator of the DSMBs and oversight of all operational DSMB activities Identifying qualified committee members through internal resources (ie. databases and networking), literature searches, etc.; verifying the qualification, credentials and eligibility of potential committee members, and serving as a liaison during the Sponsor review process Serving as the lead author in the development Charters for the Committees Planning, coordinating, and facilitating Kick off and Data Review Meetings, communicating report designs and timelines, serving as an Executive Secretary in both open and closed sessions, and maintaining all internal and external communication relevant to each committee Managing the budget and leading the financial review of the project to include invoice review and initiating payments to committee members Ensuring client satisfaction, project team management and communication, quality, and adequate resource planning and allocation QualificationsSuccessful Independent Committee Project Leaders will have: At least 5+ years of drug safety knowledge and experience with past DSMB or DMC experience preferred Substantial experience working in drug development and/or healthcare environment Project management and/or significant team leadership experience Effective written and oral communication skills with the ability to communicate timely and accurate updates to stakeholders A commitment to quality, a customer focus, strong problem solving skills, an action oriented mindset, and the ability to succeed in a fast paced global working environment Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualifications which includes an Associates/Diploma degree in any of the above with appropriate work experience The ability to travel up to 10% EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.