Primarily oversees and manages amendment phase of domestic and/or international clinical trials. Where required, may also take on start-up tasks under the direction of a Start-up Project Manager. Responsibilities include project managing defined study activities within timelines, scope, quality and budget, ensuring that client’s expectations are met.
- Develop an amendment submission and approval strategy in conjunction with the Project Lead, other functional groups and the client to ensure maintenance deliverables are completed within agreed project timelines and in accordance with client’s expectations
- Proactively manage maintenance progress, expectations and deliverables
- Understand client expectations for deliverables/milestones, and liaise with applicable functional teams in creation and modification of site activation timelines throughout the lifecycle of the project
- Oversee ethics and regulatory bodies submission and approval status. Coordinate addressing queries ensuring required timelines are met
- Oversee Investigator Package compilation and green light approval regionally and/or globally. Proactively identify and escalate any risks to meeting deliverables. Propose effective mitigation plan, as applicable
- Monitor Green Light (GL) approval regionally to ensure deliverables are met. Proactively identify and escalate any risks to meeting deliverables
- Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services
- Contribute to a Start-Up Plan if required, overseeing Investigator Package compilation, green light approval and contributing to a cross functional team ensuring that sites achieve Ready to Enrol status on time
- Support study feasibility / site ID activities
University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution. In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
Four (4) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), including demonstrated skills and competency in study start-up and/or amendment management.
Preferably local project coordination and/or project management experience
Undertaken similar activities in > 1 country for more than 6 months
Direct Sponsor contact
Experience in oversight of start-up activities
Experience outside of region
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