Collaborate closely with Global Feasibility Leads, project management, clinical management, and start up for the coordination of high-quality feasibility and site identification assessments in the pre- and post-award space. Understand the target site profile related to a program or protocol in order to quickly produce the highest quality site list for the startup team. Engage in planning and development for any informational or system-related capabilities for site identification /feasibility/site selection, in order to continuously improve processes and outputs. Manage site identification projects and deliverables according to contractual obligations, including leading client support. Lead participate in process development and change initiatives within FSS. Lead in training on departmental requirements and any other subjects that impact on feasibility or site identification conduct.
Develop a site activation and maintenance strategy in conjunction with the Project Lead, other functional groups and the client to ensure start-up and maintenance deliverables are completed within agreed project timelines and in accordance with client's expectations
- Proactively manage site activation and 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
- Support RFP development and attend at Bid Defense Meetings, if required
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.Experience:
¨ Four (4) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), including demonstrated skills and competency in clinical project management tasks, especially regarding study start-up.
¨ Preferably Local project coordination and/or project management experience, especially regarding study start-up.
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