Precision for Medicine is a Clinical Research Organization focused on precision medicine, combining novel clinical trial designs and advanced biomarker solutions, particularly in rare diseases and oncology. The company is growing and seeks dedicated professionals to support its mission, fostering a culture where employees feel appreciated and their ideas valued.
Responsible for site activation readiness, including preparation and submission of Clinical Trial Application Forms to Competent Authorities and Ethics Committees.
Manage collection of essential documents, customize informed consent forms, and coordinate translations for study-specific documents.
Maintain communication with key functions (Feasibility, Clinical Operations, Regulatory) and update project trackers and regulatory intelligence tools.
Partner with subject matter experts to assess training needs and design effective content across translational sciences, clinical operations, and regulatory areas.
Coordinate new hire onboarding and serve as primary intake for training requests, ensuring alignment with functional and GCP requirements.
Manage learning platforms, maintain training documentation, and support refinement of L&D technologies.
Review, draft, negotiate, and track legal agreements including confidentiality agreements, clinical study agreements, and amendment agreements across APAC.
Set up contracting strategies for assigned projects and work closely with Clinical Operations study team to ensure deliverables align with study timelines.
Be fully responsible for Site Contract Management from setting up site contracting strategy to execution of contracts, including budget negotiations with sites.
Partner with subject matter experts to assess training needs and design effective learning solutions across translational sciences, clinical operations, and regulatory compliance.
Coordinate new hire onboarding and maintain training documentation, records, and reporting in accordance with regulatory expectations.
Manage learning platforms, deliver instructor-led and e-learning programs, and serve as primary intake point for training requests.