Essential Functions
- Manage start-up of new projects using standard operating procedures and best practices, including identifying potential risks during project initiation and implementing mitigation measures to ensure seamless delivery at maintenance stage. Responsibilities include project planning (timelines, deliverables), scope management, quality management and project financial management.
- Manage customer interface and communication for assigned projects. Represent Lifecycle Safety on projects, serve as primary point of contact within Lifecycle Safety for all internal and external customers; liaise between internal/external customers and operational teams.
- Lead meetings with internal and external stakeholders. Provide project status updates, define processes, and manage project/planning strategy.
- Work in a customer‑centric fashion analyzing current and future customer needs and actively developing innovative, cross‑functional strategic solutions within the Lifecycle Safety service lines to meet customer needs.
- Manage finances for assigned projects/programs. Update financial systems, revenue recognition, invoicing, project budget review, project financial analysis, and pursue change orders.
- Ensure financial project performance through oversight of key performance metrics (e.g., revenue, direct costs, time‑sheet costs, contribution margin).
- Develop specialist expertise and may act as a Subject Matter Expert (SME) on departmental, regional, or global initiatives.
- Provide leadership for Lifecycle Safety virtual project teams: keep local/global Lifecycle Safety team current on project developments; lead internal Lifecycle Safety team meetings to review project processes and status. Work closely with Lifecycle Safety Operational teams to ensure projects/programs are delivered in accordance with customer expectations.
- Actively contribute during client and internal audits and inspections for assigned projects. Liaise with Quality Assurance staff and management in the compilation of corrective action plans.
- Collaborate with Lifecycle Safety Management to resolve problem areas and customer needs ensuring global consistency.
- Perform other duties as assigned.
Qualifications
- Bachelor’s Degree in Health Sciences (or equivalent experience) with 4–6 years in clinical research, including Lifecycle Safety and project management within a CRO or pharmaceutical setting.
- Strong knowledge of global clinical research regulations (GCP, ICH) and solid business acumen, including financial analysis, budgeting, and planning.
- Proven project management expertise with the ability to manage multiple priorities, navigate ambiguity, and deliver results in a matrix environment (PMP preferred).
- Excellent communication, stakeholder management, and leadership skills, including presentation, negotiation, problem‑solving, and the ability to build effective cross‑functional relationships.
#J-18808-Ljbffr…
