Responsibilities
- Provide operational and administrative support to the Global Outreach Research (GOP) program and Investigator Sponsored Trials (ISTs) involving unapproved PDx products.
- Proactively manage all aspects of IST and Global Outreach Program study-related activities including portal maintenance, protocol review, study set-up, follow-up and close-out, contracts, budgets, forecasts, and financial tracking and reporting activities relating to funding and product supply.
- Facilitate the submission and review processes for GOP and IST applications.
- Support efficient evaluation of proposals based on scientific and medical merit, patient safety, alignment to medical objectives, and budgetary appropriateness.
- For approved studies, ensure relevant workflows are processed, including contract requests and setting up of milestones according to payment guidelines.
- Support the contracting process for approved studies, including IST agreements, Materials Transfer Agreements, research and nondisclosure agreements, etc., as needed.
- Review supporting compliance documentation and file as required.
- Set up product supply process and tracking as applicable.
- Build and expand relationships with internal and external customers to facilitate project completion within timeframes consistent with IST and GOP objectives; including legal, finance, marketing, regulatory affairs, global supply chain, pharmacovigilance, medical affairs, medical expert teams, R&D, external suppliers and key opinion leaders.
- Initiate and follow-up on study management and support activities from initial submission to final report, publication and close-out.
- Place and track orders for PDx products required for active ISTs and help coordinate shipping of radiopharmaceuticals to clinical research facilities.
- Ensure all product supply is tracked and reported in line with compliance requirements.
- Review invoices for alignment to milestones and obtain proof of milestone achievement.
- Support planning and delivery of strategic events such as advisory boards, symposia, and alliance summits.
- Support the development of a structured operational model for managing research alliances and outreach programs.
- Organize and manage travel logistics for people leaders and ensure compliance with travel policies.
Qualifications
- Bachelor's degree in life sciences, healthcare, or related field (preferred).
- Experience in clinical research or healthcare project coordination.
- Ability to manage multiple priorities in a fast-paced environment.
- Prior knowledge of the clinical trial process.
- Ability to work across functions and within teams.
- Excellent oral and written communication skills.
- Well organized and structured with an attention to detail.
- Excellent interpersonal skills.
- Proficiency with document management systems and Microsoft Office suite.
Inclusion and Diversity
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