Project Launch Manager (Home-based, US)
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 Analgesia, Neuroscience, Oncology, Pediatrics, Dermatology and Rare Diseases.
We’re looking for a talented and energetic Project Launch Manager to join our team! This is a very exciting opportunity to join a dynamic and innovative team and grow with a forward-thinking organization that is changing to course of medicine.
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment 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 Project Launch Manager, you’ll have the opportunity to manage and oversee Project Launch activities of functional groups that make up the project teams! To be successful in this role, you’ll need to be proficient in the launch of newly award clinical trials. Because of this critical role, Premier Research is able to avoid the common pitfalls which place key milestones in jeopardy. You will be able to use your expertise to lead the multidisciplinary team through this critical part of the clinical trial lifecycle to ensure success leading to customer satisfaction.
What you’ll be doing:
- Oversee the on time, on budget, high quality delivery of project launch with the objective of meeting key milestones and the goal setting the groundwork for continued success throughout the life of the study. Apply best practices and lessons learned in the development, planning and launch of projects
- Coordinate efforts for the launch within Premier Research, the Sponsor and third-party vendors
- Establish and maintain full communication across the project team by interacting with functional groups for Project Launch activities from award through completion of Startup; facilitate internal cross-functional communication including but not limited to Finance, Business Development, Strategic Development and Regulatory departments until the end of Startup; communicate project launch risks to the Project Leader and leads resolution of project related conflicts with necessary corrective/preventative actions and alert Project Leader to potential issues
- Establish standard core project plans, documents, templates and project timelines across multiple functional departments; review and ensure drafted plans developed by functional leads are submitted to clients prior to Kick-Off Meetings and fully signed off by Premier and Sponsor following the meeting
- Ensure adherence to project budget and scope of work during Startup.
- Ensure team training is in accordance with protocol and/or project requirements, including therapeutic, protocol specific and process training
- Prepare for and conduct Internal and external Kick-Off Meetings, including ensuring necessary resources are identified, developing draft project plans and timelines, collating questions that require input from the client and ensuring key systems including Working Directory, SFTs, study email boxes, and LMS are activated
- Track and review timelines for all Project Launch activities for assigned projects and ensure that the Project Leader is kept up to date with the latest status
- Monitor the quality of project deliverables and addresses quality issues with the appropriate team members
- Ensure appropriate transition planning for completion of the Startup phase
You’ll need this to be considered:
- Undergraduate degree and 5+ years’ experience in managing or assisting with the management of clinical trials with progressive complexity, at least half of which has been in a matrix environment
- CRO experience required
- Established experience with delivering Startup milestones on time and with high quality; participating in the development of core project documents including Project Management Plans, Clinical Monitoring Plans, Communication Plans, and Data Management Plans
- Knowledge of ICH GCP and local regulatory authority regulations required
- Determination, energy, aptitude, and passion to work on short term, high-intensity, highly visible projects/assignments
- Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites, clients, vendors and other functional areas; strong verbal and written communication and negotiation skills
- Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team; strong ability to influence project team performance
- Excellent organizational and time-management skills, able prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strong commitment.