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
- Develop, in conjunction with the Global Feasibility Lead, the initial site list for feasibility and site identification
- Full oversight of the Feasibility/Site identification process: survey development and programming, local resource training and oversight, oversight of site outreach process, creation of progress reports, site selection tool and decision making, customer interaction
- Collaborate with Global Feasibility Leads to support collection of country and investigator feedback in the pre-award space; provide summary and analysis of results
- Responsible for setup and conduct for feasibility/site identification studies according to timeline and quality standards and client expectations - learning to negotiate timelines or KPIs directly with customers
- Develop site lists according to the program or protocol:
- Work closely with Global Feasibility Lead, strategy, and start up teams to understand optimal site profile
- Evaluate the available sources of potential site information, and the pros and cons of each.
- Manage timelines and any changes to the target site list requirements up until the site is fully identified and the target number of potential sites in each defined region and country is achieved.
- Helping to facilitate identity matching by coordinating the triggers for master data management
- Independently performs literature and internet searches as required.
- Masters and fully exploits all available data sources for site performance.
- Create electronic surveys using company software and produce any required standalone or topline surveys
- Trains and mentors SSL1, and newer SSL2s as needed, on core feasibility processes for all core feasibility tasks required of that role
- Participates in, contributes, and potentially leads process improvement or special projects
- Contribute to (and learn to potentially lead) internal planning meetings, client interactions, and interim teleconferences.
- Ensure accuracy and quality of survey driven data
- Work with team to identify potential risks and out of scope activity; discusses contingency plans with stakeholders as appropriate.
- Ensure site identification team in each country is entering and updating internal tracking tools.
- Contribute to best practice for feasibility/site identification conduct.
- Contribute and deliver training of feasibility and site identification requirements/processes
- Liaise with the global, cross-functional teams, inclusive of legal, start-up, clinical, country teams, and project management.
- Contribute to audit presentations/documentation based on site ID oversight
- Performs any other duties as assigned
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 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
You should have strong Excel skills and an aptitude for data analysis
Experience in oversight of start-up activities
Experience outside of region
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