- Partners and collaborates with peers across the organization in order to achieve client-centric delivery in a matrix organization. In particular, collaboration across all stakeholders within Start-up.
- Mentors and advises Start Up staff in their day to day work
- Assesses staffing and resourcing needs to ensure maximum Start Up staff utilization
- Allocate Start Up team members to projects as required, based on experience and availability.
- Interviews, evaluates and recruits new Start Up staff as required while providing recruitment and retention initiatives for existing Start Up staff
- Identifies Start Up staff training and development needs and ensure requirements are met.
- Manages employee performance and employee development in a proactive manner.
- Promote and review and evaluates quality and performance metrics (departmental, individual and project specific) for Start Up and ensure these are adequately documented and communicated. If needed the Senior Manager puts adequate actions/mitigation plans in place
- Contribute to the development of the group through leading and participating in process improvement initiatives.
- Ensure Start Up project deliverables are completed within agreed project specific timelines and in accordance with sponsor expectations and in compliance with SOPs and/or other quality and regulatory requirements
- Serve as an issue escalation point for concerns either from the external/internal project team members or other staff.
- Participating in client-hosted audits (for completed/active project(s)) and audit responses, attending project specific audits and pre-qualification audits.
As applicable and assigned by management:
- Provide support to Business Development, including attending strategy calls, providing information for RFI and RFP responses, and bid defense meetings. Attend bid defense meetings if required.
- Review financial performance of allocated employees (which may include but is not limited to: resource assignment, revenue forecast and recognition, pricing, budgets, and profit margins).
- Oversight of transactional clients.
- Coordinate and Lead Project/Country Reviews
- Perform any other duties as required by the department
- 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.
- Working knowledge of financial control procedures (e.g. costing systems, time reporting).
- Working knowledge of project management/line management processes, preferably regarding study start-up.
- Working knowledge of time and cost estimate development.
- Working knowledge of ICH Guidelines and GCP including local and/or 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 or similar certification.
- Working knowledge of Covance and the overall structure of the organization.
- Working knowledge of Covance sales and business development strategies and procedures.
- Working knowledge of Covance SOPs.
- Four (4) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), preferably including three (3) or more years project management/line management responsibility / preferably in in Study Start-up.
- Demonstrated ability to handle multiple competing priorities.
- Ability to utilize resources effectively.
- Financial awareness and ability to actively manage financial tracking.
- 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.
- Experience mentoring junior level staff.
- 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.
- Good computer skills with good working knowledge of a range of computer packages.
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