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, and rare diseases.
We’re looking for a talented and energetic Senior Project Manager to join our team in the US - this role can be office based in RTP, North Carolina or home based in the US!
You’ll be accountable for:
Ensuring successful management and coordination of work assigned to members of the project team, including regulatory, clinical operations, biometrics, and medical affairs/safety.
Adhering to the project budget and scope of work to ensure profitability.
Ensuring that tasks are completed in accordance with project plans and in compliance with Premier Research processes, policies, and procedures.
Managing resources to ensure that adequate staffing is available to meet project deliverables and milestones.
You’ll need this background to be considered:
Undergraduate degree in a clinical, biological, scientific, or health-related field.
Minimum of four years’ relevant experience in a pharmaceutical company, medical device company, or CRO, including trial management experience. At least one year of experience as a clinical manager or project lead is preferred.
Good therapeutic and protocol knowledge.
Budget/finance experience on a project level.
You’ll need demonstrated knowledge of:
Therapeutic and protocol disciplines.
FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures.
Basic project management principles.
Full-service functional areas.
Web-based communication tools for conferences.
You also must be:
Available to travel.
Fluent in English, with strong oral and written communication skills.
Able to lead and motivate team members.
Skilled at multitasking, meeting deadlines, and working effectively in a fast-paced environment with competing priorities.
Skilled at handling problems decisively and objectively.
Among the top five Contract Research Organizations (CROs) for consistently delivering services that meet customer expectations. We have developed a surprising concentration of experience for a mid-sized CRO:
- Over 700 trials for virtually every major class of analgesic, including every NSAID pain medication on the market today
- Approximately 100 rare disease studies in the past 5 years
- Pe...diatric experience with both familiar and extremely rare childhood illnesses, including work at PICUs, NICUs, clinics, and ERs—and a hard-to-match track record of successful neonatal studies
For the future, we plan on continuing to focus on serving the needs of the small, highly innovative companies whose developments are changing medical history, especially in the areas of pediatric medicine and rare diseases. We will offer them everything they need to transform their brave new ideas into break-through therapies.