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Manager, IRT Center of Excellence

Basking Ridge, NJ 07920

Posted: 10/02/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 615093 Is job remote?: Yes Country: United States

Job Description


Target Pay Rate: 35-45/hr **salary will be commensurate with experience 

Job Description:

This position is responsible for managing Interactive Response Technology (IRT)-related activities across multiple clinical trials and / or at the vendor level according to Good Clinical and Manufacturing Practices (GCP. GMP), and Daiichi Sankyo standard practices. A successful candidate will be responsible for providing subject matter expertise in IRT while driving the development and delivery of IRT systems across global matrixed teams.

Manage and coordinate IRT-related activities and timelines during study initiation, start-up, conduct, closeout, and archival. These activities will include: Providing input into the Request for Proposal (RFP) process and protocol development process for assigned clinical trials; Managing and contributing to the IRT system development lifecycle, including requirements gathering, user acceptance testing, issue management, change management and decommissioning activities, to minimize unanticipated impacts across programs and stakeholders; Supporting transparency in operational planning through tracking IRT-related milestones and dashboard inputs; and Ensuring inspection readiness of IRT-related items for assigned clinical trials.

Conduct oversight of assigned IRT vendors, ensuring timelines and data quality standards are met.

Support compliance audits, IRT vendor audits and regulatory inspections.

Lead and/or contribute to cross-functional and global improvement projects including IRT-related data and/or IRT vendors.

Skills:
  • Minimum 4 years of related experience in life sciences or medically related field including 3 years of supporting pharmaceutical/biopharmaceutical clinical research experience (obtained by working on clinical trials at a pharmaceutical, biopharmaceutical, CRO or relevant vendor)
  • Minimum of 4 years direct experience leading IRT-related projects with cross-functional stakeholders preferred
  • Experience leading IRT-related projects across global teams preferred
  • Oncology experience is preferred
  • GCP, ICH and/or familiarly with global regulations and standard industry practices
  • Understanding of GMP requirements as they relate to IRT systems
  • Self-starter with the ability to work independently with a high-level attention to detail
  • Problem solver who presents and drives solutions to issues and other IRT-related concerns
  • Ability to deal with time demands, incomplete information and prioritize assigned tasks
  • Ability to maintain a professional demeanor despite demanding deliverables
  • Flexible, team-oriented
  • Demonstrated multi-study/program/global leadership

Education:
BS/BA required. Degree in sciences or related field preferred.


**CO/NY candidates may not be considered 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Basking Ridge, NJ

Discover exciting job opportunities in the vibrant area surrounding Basking Ridge, New Jersey! Known for its picturesque landscapes, rich history, and thriving business community, Basking Ridge offers an unparalleled quality of life for professionals seeking growth and success. With easy access to NYC and iconic landmarks like the historic Jacobus Vanderveer House and the stunning Scherman Hoffman Wildlife Sanctuary, this charming region provides a perfect blend of career prospects and leisure pursuits. Indulge in locally sourced cuisine, catch a show at the elegant Ridge Performing Arts Center, or explore the natural beauty of Lord Stirling Park. Embrace the unique culture and endless possibilities that Basking Ridge has to offer as you explore our latest job listings and embark on a fulfilling career journey in this enchanting area.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.