The Clinical Operations Planner possesses a comprehensive knowledge of drug development, resource management concepts, associated business processes, and project planning software and plays a key role in scenario planning, i.e., building schedule options and forecasting associated development costs that depict various development options.
You will be joining a program that takes an extensive co-monitoring approach that enables a supportive and collaborative work environment. Frequent, consistent communication, both internally and with our client, positions our program to be closely aligned on our shared goals.
What you will be doing:
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.
- 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 (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.
You are:
- Bachelors level degree.
- S. with 5+ years' experience or M.S. with 3+ years' experience.
- Solid experience in project planning and project management
- Solid experience in pharmaceutical industry experience or similar industry experience.
- 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.
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
