Clinical Trial Planner

This is a fully remote position, open to applicants in Spain, +1 more country.

📋 Description

• Create detailed timelines for Clinical Sub Teams and studies, managing the process from protocol concept through to database lock and closeout, ensuring alignment with the Asset Level Plan.

• Collaborate with various stakeholders, including the Clinical Project Manager and Asset Operations Lead/Asset Planner.

• Recognize critical path activities and their scheduling dependencies.

• Develop and maintain plans based on different scenarios.

• Predict milestone delivery dates utilizing data-driven assumptions.

• Evaluate the impact of changes and suggest mitigation strategies.

• Assist IPSEN in refining and developing standardized Clinical Sub-Team Plans and Study Plans.

• Set up governance and tracking mechanisms for Clinical Sub Team planning that align with Asset Level Planning processes.

• Aid the Clinical Project Manager in managing risks, issues, assumptions, and dependencies.

• Track progress against established baseline plans.

• Support resource allocation and capacity planning efforts.

• Partner with the Clinical Project Manager to ensure accountability for achieving milestones.

• Present schedules and forecasts in formats suitable for executive review.

• Create planning dashboards.

• Effectively communicate risks and recovery plans.

• Customize messaging for both operational teams and leadership audiences.

• Document lessons learned.

• Standardize planning methodologies.

• Enhance the accuracy of forecasting.

• Promote initiatives aimed at operational excellence.

• Advocate for best practices and innovative solutions.

• Ensure the quality and completeness of study plans, including conducting quality reviews.

• Prepare and deliver training sessions for CDO colleagues to facilitate the adoption of study-level OnePlan standards and tools.

• Serve as the CDO Subject Matter Expert on planning templates and processes.

⛳️ Requirements

• Extensive knowledge of planning tools, preferably OnePlan, while experience with Plannisware or similar tools is also acceptable.

• Strong grasp of the clinical trial planning ecosystem, such as CTMS/OnePlan.

• Proven experience in developing and maintaining clinical sub-team and study timelines from the protocol concept to database lock and closeout.

• Experience in coordinating with Clinical Project Managers and Asset Operations Leads/Planners.

• Capable of identifying critical path activities and scheduling dependencies.

• Proficient in building and maintaining scenario-based plans.

• Skilled in forecasting milestone delivery dates based on data-driven assumptions.

• Competent in assessing the impact of changes and proposing mitigation strategies.

• Experienced in supporting resource and capacity planning.

• Adept at presenting schedules and forecasts in executive-friendly formats.

• Capable of developing planning dashboards.

• Effective in communicating risks and recovery plans.

• Skilled in tailoring messages for both operational and leadership audiences.

• Able to capture lessons learned and standardize planning methodologies.

• Proficient in enhancing forecasting accuracy and driving operational excellence.

• Responsible for ensuring the quality and completeness of study plans.

• Capable of preparing and conducting training for CDO colleagues.

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive company culture.

• Reasonable accommodations provided, when appropriate, to assist employees or applicants in performing essential job functions.