Project Manager, Rare Disease and Pediatrics (EU)
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices.
We’re looking for a talented and energetic Senior Project Manager with Rare Disease and Pediatric experience to join our dynamic Specialty Areas Franchise Team!
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact in an aspiring, empowering and caring culture where people truly work as one team. You can grow and contribute your expertise with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
As the Sr. Project Manager, Rare Disease and Pediatrics, you'll have the opportunity to showcase your expertise to successfully lead, plan, organize and oversee all activities related to the successful execution of complex and international clinical trials and programs. You’ll also manage and coordinate the efforts for all members of our highly talented global project team, including Regulatory, Clinical Operations, Biometrics and Medical Affairs / Safety to support milestone achievement and overall project delivery. In this role, you’ll provide customer-focused leadership from inception to execution through completion to achieve on-time, on-budget project results with high quality.
What you'll be doing:
- Act as the primary liaison between Premier Research and the customer for assigned projects and chairs project team meetings; monitor and manage customer satisfaction; develop strong relationships with current clients to generate new and add-on business for the future
- Manage the project team to ensure study progress is according to client and Premier Research requirements; ensure adherence to project budget and scope of work to realize project profitability
- Facilitate team training, including therapeutic, protocol specific, and process training
- Develop project plans for all phases of the project lifecycle, including quality, risk management and proactive contingency plans, ensuring that issue escalation and resolution is clear
- Facilitate communication across the project team and departments
- Maintain, evaluate and communicate study progress by using company tracking systems, timelines and budget reviews; provide project progress, including performance, customer expectations and project baselines
- Monitor the quality of project deliverables and address quality issues; facilitate creative resolution of project related conflicts with necessary corrective and preventative actions
- Ensures adequate resourcing is available to meet project deliverables and milestones; prepare forecasts for staff utilization over the life of the study; ensure appropriate transition planning and stakeholder communication for any change in staff
- Oversee project documentation, ensuring Trial Master Files are completed and “audit ready”; supports study audits and responds to audit reports
- Review and approve project expenses and ensure all study related contractual and budgeting issues are addressed; provide accurate information to ensure timely invoicing and allow for accurate forecasting
- Identify scope of work changes across all functional areas and secure Change Orders
- Apply your expertise to assist in Business Development activities, including proposal development and leading proposal presentations in partnership with Business Development and Scientific Leadership
- Identifies, recruits and manages central vendors as required per project scope
You'll need this background to be considered:
- Undergraduate degree, preferably in a clinical, biological, or science-related field along with 5 years’ experience, preferably in a pharmaceutical company/medical device company/CRO including 2 years’ as a Project Manager managing complex trials, multiple phases and full lifecycle for Rare Diseases.
- Proven financial acumen to Budget/finance/costing experience on a project level
- Known for successful coaching/mentoring other PMs
- Knowledge of ICH/GCP regulations and strong working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
- Strong knowledge of the principles of project management, the clinical development process and full service functional areas
- Highly confident and effective presenter with knowledge of web based communication tools; excellent verbal and written communication skills with a customer-service focus
- Maintain a positive working environment that embodies a culture of aspiration, caring, empowerment and a #oneteam approach; excellent team player who encompasses the management skills to motivate, enthuse and lead teams; accountable, dependable and strong commitment
- Excelled organizational and time-management skills with the ability to multitask, meet deadlines and work effectively in a fast-paced environment with competing priorities
- Self-starter with common sense and able to act on own initiative
- Ability to apply clear and consistent performance standards as well as identify concerns and resolve decisively and objectively