Create, manage, and maintain integrated study schedule in MS Project, including Key Event Maps, Roadmaps, and critical path visualization aligning in Planisware.
Assure Clinical timelines in Planisware align to MS Project schedule and coordinate the integrated clinical plan with Clinical Development Team project plans.
Ensure proper resource demand is reflected.
Develop scenarios in Planisware for budget, timeline, and FTE forecasting, while generating situational operational scenarios.
Collect, consolidate, and report financial, timeline and resource data for governance approvals and external funding partnerships.
Manage scope control, FTE and Out of Pocket variances.
Document key decisions, actions, risks, issues, and lessons learned, as well as maintain trial governance documentation.
Ensure risks are captured and monitored.
Ensure budgets are effectively managed and forecasts adjusted to reflect current thinking.
Drive and facilitate after action review meetings and results are documented.
Work with the team to assess and remediate impact to scope, budget, timelines.
Provide support for team-based reporting.
Mentor & support onboarding of new team members, particularly those in Trial Management.
Requirements
Bachelor’s degree required
Minimum of 4 years in Pharmaceutical, Healthcare or related industries
Strong Project Management experience
Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness
Experience leading without authority and in multi-functional matrixed and global environments
Excellent decision-making, analytical and strong financial management skills
Strong communication and presentation skills
Up to 10% travel – Domestic & International
Knowledge of Clinical Research Operations preferred
2-3 years of experience managing multiple aspects of the execution of global clinical trials (Phases I-IV) preferred
Benefits
Vacation –120 hours per calendar year
Sick time
40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time
up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year