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Independent Committee Project Leader - DMCs/DSMBs

Employer
Parexel - USA
Location
United States
Salary
Competitive
Start date
25 May 2022
Closing date
8 Jun 2022

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Discipline
Medical Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Job Description

Parexel’s growth continues to continue!

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


Qualifications

Successful 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% may be required in the future
Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That’s Parexel. We’re a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn , YouTube , Facebook , Twitter , and Glassdoor .

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

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