When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
PXL FSS has an exciting opportunity for a candidate with strong project leadership skills in Canada.
This role is responsible for performing important project planning activities in support of team deliverables and the PRD portfolio. To effectively execute the primary responsibilities, the Manager, Project Planner must possess a comprehensive knowledge of the principles, concepts, and theories of project management. The colleague executes his/her role by partnering with the Asset PM in support of Development, Operations, and Commercial project team members and partner line representatives to create project schedules that enable effective planning and ensure project delivery. The colleague is expected to apply technical, team, and line knowledge along with comprehensive scheduling knowledge to contribute to the achievement of work team deliverables
Planning/Controlling (Scheduling and Resource Management)
- Responsible for coordinating, monitoring and reporting project schedule and resource management information to enable alignment of PRD and partner line schedules and FTE/dollar resources. These schedules include:
- The cross-functional schedules (Product Group and Candidate Plans) that integrate schedule information across all lines supporting PRD at all stages of the development continuum.
- Clinical study plans (Protocol Development to Final Clinical Study Report) and Clinical Operation Submission activities to support Module 1 and 5 of the submission plan.
- Submission plans in collaboration with the PMSO submission group.
- Selected commercial launch plans
- Identifies and raises schedule conflicts, risks, and resource peaks/troughs appropriately for resolution.
- Directly participates in and contributes to cross-functional and functional teams to discuss, review, and optimize protocol/project/program schedules and study cost estimates.
- Directly participates in and contributes to cross-functional and functional teams to discuss, review, and optimize protocol/project/program schedules and resource management plans.
- Monitors progress of project activities towards next project milestone, anticipates and highlights potential variances, supports line/team in critical path analyses and understanding the impact, and partners with the Asset PM, Clinical Operations, and the project team to identify/recommend solutions to schedule risk.
- Performs scenario planning of project timelines within and across protocols and across therapeutic area/portfolio to enable optimum use of local, global, and outsourced resources to ensure efficient delivery of project milestones.
- Contributes to the validation of resource information at the project level with the project teams.
Project Execution and Delivery
- Partners with key team members (e.g., PMSO, Medicinal Sciences, CS&O, DSRD, Commercial) to manage the project and achieve key milestones according to the endorsed timeline, cost, and quality parameters.
- Supports negotiations in the allocation of line resources to support the endorsed development plan.
- Contributes to risk management through the identification of operational and project/program risks for discussion with appropriate team leadership. Participates in team discussions to de-risk projects and develop new options to resolve moderately complex issues.
- Provides the Portfolio Management group with project schedule information to enable effective portfolio management activities
Analysis and Reporting
- Produces what-if scenario analyses (base, optimistic and pessimistic development) based on context obtained from project team members (e.g., PMSO, Medicinal Sciences, CS&O, DSRD, Commercial). Decisions taken by the team based on these analyses may impact project delivery, costs, and resource requirements.
- Reviews own work regarding quality of schedule and resource metadata through utilization of quality reports and monitoring/management of such data with the team/line members.
- Provides timely reporting to the Asset PM, Portfolio Management, and project teams, alerting them to the possibility of endangered/missed or conflicting milestones and critical path activities.
- Ensures regular information updates and analysis and interpretation of planning and forecasting data to project teams, Portfolio Management, platform lines, and management teams.
- Utilizes available reporting and visualization tools to support governance and team reporting needs (e.g. OnePager, Business Objects, Spotfire).
- Provides context to local customers of reports generated globally and consolidates customer feedback to enable improvement of existing reports and generation of new reports.
Process
- Partners with project team members (e.g. PMSO, Medicinal Sciences, CS&O, DSRD, Commercial) to identify opportunities and potential solutions to realize efficiency in the development process.
- Contributes to continuous improvement of project plans, plan generation, plan utilization, and/or report creation/development processes.
- Collaborates with colleagues to ensure cross-team, site learnings, and best practices are shared.
- Promotes partner lines/teams taking ownership of data within planning tools to help them manage their business.
QUALIFICATIONS / SKILLS
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
Education
- Bachelors level degree.
- B.S. with 5+ years' experience or M.S. with 3+ years' experience.
Experience
- At least 3 years experience in project planning and project management.
- At least 3 years of applicable pharmaceutical industry experience or similar industry experience.
Beneficial Relevant Capabilities
- Project Management Professional (PMP) certification preferred but not required.
- Experienced in end-game/regulatory submission planning and/or product launch planning.
- Experienced with planning and resource forecasting tools (e.g., MS Project, Planisware, OnePager).
- Experienced user of reporting and office software (e.g., MS Office, Business Objects, Spotfire).
- Trained/experienced in negotiation, facilitation and managing cross-functional team dynamics.
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