Evidence Delivery Specialist

• Executes activities to fulfil sponsor oversight responsibilities and to maintain inspection-readiness, including Maintain Study Inspection Readiness Tools
• Coordinate and oversee periodic study-level TMF/Master File (MF) QC
• Perform Periodic TMF/MF QC on behalf of Study/EAP Management
• Customization of the study's Expected Document List (EDL) in collaboration with the CROs
• Collaborate with extended study team to develop, maintain, and execute activities according to the study Sponsor Oversight Plan
• Ensure appropriate documentation of oversight and inspection-readiness tasks is maintained
• Ensure handover documents are created, signed and filed in TMF
• In collaboration with CRO, support creation, execution and maintenance of TMF/MF Plan
• Supports key study start-up activities, in collaboration with CRO and internal functions as needed
• Support compliance and quality deliverables
• Create and maintain internal study/program trackers and systems as needed, including mailboxes and collaboration forums
• Support budget management activities including

• Bachelor's degree required preferably in medical or biological science or equivalent by experience
• Knowledge and understanding of the clinical study and drug development processes, GCP/ICH guidelines
• Excellent written and verbal communication skills as well as proven collaboration and influencing skills
• Team oriented and flexible
• ability to respond quickly to shifting demands and opportunities
• Demonstrated ability to collaborate as well as work independently
• Ability to effectively work with Clinical Research Organizations/External Providers
• Preferred background in medical affairs/investigator initiated studies
• Proven ability to interact widely and effectively within the company across regions, functions and culture
• Ability to manage competing priorities

Preferred background in medical affairs/investigator initiated studies

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others