+ Lead core project team(s) and facilitate team's ability to lead extended/complete project team.
+ Responsible for provision of client deliverables on-time, within budget and scope and with required quality for assigned projects or program.
+ Develops strategies to control and improve financial margin and minimize write-offs across projects and/or programs while maintaining quality.
+ Proactively identify out of scope activities, execute necessary change orders and support negotiations with client on project budget issues.
+ Accountable for budget across assigned projects and/or programs.
+ Responsible for mitigation plans where variance occurs in execution of deliverables to plan
+ Structures work and organization effectively and efficiently.
+ Grows people within and across the organization.
+ Puts people into roles which maximize their contribution and organizational effectiveness.
+ Develops deep leadership bench beneath oneself
+ Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services.
+ Effectively and proactively resolve conflicts as needed.
+ Demands high performance on all strategy initiatives
+ Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects or programs.
+ Ensure that all staff allocated to assigned projects or programs adhere to professional standards and SOPs.
+ Provide performance feedback on team members to respective functional line management
+ Monitor team performance and facilitate adjustments when necessary to ensure goal attainment.
+ Present at external and/or internal meetings.
+ Define and manage project or program resource needs and establish succession plans for key resources.
+ Support business unit utilization targets.
+ Implement and monitor progress against project plans and empower team to revise as necessary.
+ Responsible for appropriate issue escalation via CAIR and CAPA processes
+ Serve as key client contact for assigned projects.
+ Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business.
+ Tums ideas into processes and/or sales which drive growth.
+ Prepare and deliver presentations for new business in collaboration with business development.
+ Prepare and actively participate as operational lead in internal Project Review meetings.
+ Contribute to proposal strategy, development, costing, and bid defense for assigned business development opportunities.
+ Able to discuss global strategic options and study execution challenges/oppo1tunities with the
client during the proposal development/bid defense
+ Delivers visible leadership with clients through effective problem solving and generation of customer solutions.
+ Find creative and cost-effective ways to meet quality metrics agreed with client and key stakeholders.
+ Use experience from past projects and lessons learned to adapt and implement quality improvements across projects currently being managed.
+ Ensure project risks are discussed at project reviews. Monitor and control the risk plan and provide ongoing oversight to ensure mitigation plans are in place and working. Escalate risks newly identified by the project team to stakeholders.
+ May be assigned line management responsibilities for the recruitment, training, utilisation, development and performance review of assigned staff. In the absence of line management responsibilities, the Project Director will be expected to mentor project management staff.
+ Develop and manage client project metrics.
+ Perform other duties as assigned by management.
+ Assist in the implementation of study training plans. Ftmction as the trainer where appropriate .
+ University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from om an appropriately accredited institution.
+ Detailed knowledge of financial control procedures ( e.g. costing systems, TAQ /EVA).
+ Thorough knowledge of project management processes.
+ Thorough knowledge of time and cost estimate development.
+ Thorough knowledge ofICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
+ Broad knowledge of drug development process and client needs.
+ Masters or other advanced degree.
+ PMP ce1tification
+ Detailed knowledge of Covance and the overall structure of the organization.
+ Basic knowledge of Covance sales and business development strategies and procedures.
+ Thorough knowledge of Covance SOPs
+ Minimum of nine (9) years relevant clinical research experience in a pharmaceutical
company/CRO, including at least four (4) years of full project management responsibility.
+ In lieu of the above requirement, candidates with > six (6) years supervisory experience in a heath care setting and> seven (7) years clinical research experience including four ( 4) years of international project management experience in the pharmaceutical or CRO industries will be considered.
+ Experience in managing global programs with large financial value and complicated structure, multiple vendors and/or sub-CROs and Academic Research Organizations in a virtual environment.
+ Demonstrated ability to handle multiple competing priorities
+ Ability to utilize resources effectively on large global scale including programs with multiple budgets
+ Financial awareness and ability to actively manage 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.
+ Excellent presentation skills and confidence presenting to senior management.
+ Excellent communication, planning and organizational skills.
+ Ability to work independently.
+ Ability to negotiate and liaise with clients in a professional manner.
+ Ability to present to staff at all levels.
+ Ability to mentor junior level staff
+ Good computer skills with good working knowledge of range of computer programs
+ Ability to assess technology alternatives and implications in line with relevant functional areas
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