Remote USA or Canada
- Lead start-up team during study start-up phase liaising directly with Lead SUPM or Project Lead, core team members and the client.
- Serve as client's contact for start-up and maintenance processes and oversight.
- Responsible for establishing a strong working relationship with client's project teams.
- Monitor and control start up project schedule, budget, and scope.
- Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met. Initiate improvements to enhance the efficiency and the quality of the start-up work performed on assigned projects.
- Ensure that work is performed within the budget. Interpret billing guidelines for the functional area/region and schedule training for start up team accordingly.
- Proactively identify risk of over-spend and track project progress against financial milestones using applicable financial systems.
- Implement and follow pre-approved procedures for write off or budget overages.
- Determine needs, request and manage project start-up resources. Adapt/request resources as applicable to ensure project deliverables are met.
- Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services.
- Resolve conflicts as needed.
- Escalate non-compliance related to maintaining professional standards, following processes and SOPs to respective line managers and/or QA.
- Schedule and conduct start-up related trainings, as applicable to project teams (both internal and external).
- Ensure local staff has access and are trained on applicable systems.
- Provide performance feedback of team members to respective line managers and project management team.
- In a lead role, 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.
- Create or review required project start-up plans. Distribute, implement and monitor compliance to project plans and revise as necessary. Review Client vs CRO responsibilities related to start-up.
- 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.
- Review and provide input to core study documents, as applicable.
- Proactively manage site activation and maintenance progress, expectations and deliverables to a Lead SUPM or the Project Lead/client, as applicable.
- Present at external and internal meetings including, but not limited to: project core team and client meetings, Chapter Meetings, Kick Off Meetings.
- Distribute start-up and maintenance related documents to local start-up staff and oversee the customization to local requirements.
- Oversee ethics and regulatory bodies submissions and approval status. Coordinate addressing queries ensuring required timelines are met.
- Ensure preparation and distribution of core and country specific contract and budget templates to applicable project team members.
- Oversee Investigator Package compilation and green light approval regionally and/or globally. Proactively identify and escalate any risks to meting deliverables. Propose effective mitigation plan, as applicable.
- Monitor Green Light (GL) approval and Site Ready to Enrol (RTE) regionally to ensure deliverables are met. Proactively identify and escalate any risks to meeting deliverables.
COVANCE LEADERSHIP OVERSIGHT/QUALITY ASSURANCE
- Prepare and present as operational lead in internal Project Review meetings, if in a lead role. Depending on the scope of project, this job duty may be performed in collaboration with a Lead SUPM, Start-up Senior Project Manager, and/or Start-up Project Director.
- Responsible for appropriate issue escalation to QA Triage and/or appropriate stakeholder(s).
- Support audits (internal and external) and inspections, as needed. Support resolution of any findings.
- Support RFP development and attend at Bid Defense Meetings, if required
- Mentor Associate SUPMs
- Perform other duties as assigned by management.
- 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 five (5) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
- Masters or other advanced degree.
- PMP certification.
- Working knowledge of Covance and the overall structure of the organization.
- Basic knowledge of Covance sales and business development strategies and procedures.
- Working knowledge of Covance SOPs.
- Five (5) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), preferably including two (2) or more years project management responsibility / leading clinical trials in Study Start-up.
- Experience in managing projects in a virtual environment.
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
- Financial awareness and ability to actively utilize financial tracking systems.
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
- Excellent communication, planning and organizational skills.
- Ability to review/analyze and report relevant data and interpret protocols and regulatory documents.
- Ability to work independently.
- Ability to negotiate and liaise with clients in a professional manner.
- Ability to present to staff at all levels.
- Strong computer skills with an ability to understand, access and leverage technology alternatives.
- A working knowledge of ICH GCP, US FDA regulations, regulations applicable to local office, guidelines, and practices regarding Good Clinical Practices.
- Detailed knowledge of financial control procedures (i.e. costing systems, time reporting).
- Working knowledge of project management processes, especially concerning study start-up.
- Working knowledge of time and cost estimate development.
- Broad knowledge of drug development process and client needs.
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