Description Position at Premier Research Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.We're looking for an exceptional Director, Project Management RWLP to bring your passion to our team.
You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority.
Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered.
Join us.What you'll be doing:
The Director of Project Management takes overall responsibility for line management of assigned project manager and/or project director staff including collaboration with the global resourcing team on assignments as well as activity and metrics reporting.
The Director also ensures that the client's goals of time, cost, and quality performance are met.
The Director may also act as the senior liaison with, and may have overall responsibility for assigned clients.Provides leadership and is accountable for the work of professional staff and managers within Project Management functionIs accountable for recruitment of staff, including interviews in collaboration with corporate recruitment organization and subsequent onboarding.Drives customer goals in terms of scope, time, costs and quality performanceRepresent Premier Research to the customer, ensuring satisfaction levels are maintained and deliverables are maintained effectively.Drives operational excellence by identifying best practices and gather global ideas for innovation and continuous improvements within Project ManagementProvides line management for assigned staff to include performance management, career development and advice on training needs, coaching and mentoring as appropriate.Is responsible for inspection readiness of all elements of personnel management and training.Is responsible for assuring completion of all tasks assigned to Project Management staff.Provides knowledgeable, demonstrated leadership of clinical research requirements to Premier Research staff.Gives technical support to Project Managers as appropriate.Actively leads project review process.Provides the PM & the team with structure, processes & tools while supporting and controlling projects for successful delivery.Provides a comprehensive, consistent project management methods by defining documenting and communicating reliable, repeatable project practices.Approves project expenses and ensures all department/customer related contractual and budgeting issues are upheld and performed.
Provides mentorship with invoicing and site payment issues as required.Provides senior management project progress reports on project activitiesas requested.In collaboration with the global resourcing team the Director, Project Management will oversee and contribute with:
Resourcing allocation.Resourcing planning, including assessment of continuous gap analysis to assess hiring needs.Resource realization to a planned variance target on a quarterly basis, managed monthly.Review resourcing needs/management with senior management including monthly reconciliation to actual performance.Responsible for oversight and providing mentorship to direct reports for project variance and scope:
Attend monthly Project Status Meetings.Provide input on a continuous basis by monitoring project activities related to clinical aspects of budget.Engage in CO needs Importante Azienda project lifecycles.Based on predictive resourcing gaps provide feedback Importante Azienda PSR and ongoing.Provide daily availability to RFP triage.Focus on operational budget assessments and resourcing strategies.Work with proposal/finance on costing models as required.Assists in Business Development activities supporting production of Proposals and attends bid defence meetings where required.
May participate in prospective study feasibility assessment as required.Projects are delivered on time and within budgetParticipate in corporate initiatives and actions that ensure the continued success of the companyOther activities as designatedWhat you'll need:
Minimum of a Bachelor's degree (BS, BA or RN equivalent) required; biological
- or science-related field preferred (advanced academic degree is preferred)Minimum of eight (8) years' experience managing personnel and projects in a CRO environment.Demonstrated leadership and mentoring skills required.Demonstrated experience in forecasting, managing and prioritizing resource assignments required for the effective and efficient management/conduct of multiple clinical trials at varying points of their lifecycle, including complex multi-protocol programs.Knowledge of ICH / GCP regulations.Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures.Knowledge of web based communication tools for conferences.Ability to effectively manage and motivate direct reports with project and people management responsibilities.Ability to work independently as well as part of a project and leadership team.Able to handle and prioritize multiple assignments in a fast-paced work environment.Excellent customer service orientation, both internally and externally, with strong organizational, interpersonal and communication skills.Detail-oriented and well organized, with highly developed problem-solving capabilities.Demonstrated thorough understanding of costing for tasks involved in clinical trial conduct.Excellent computer skills, including MS Word, Excel, PowerPoint, Outlook.Excellent presentations skills are required.Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.Strong verbal and written communication and negotiation skills.