Clinical Lead II - Remote (United States)
At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.
We’re looking for a Clinical Lead II to join our Clinical Management team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.
What you'll be doing:
- Driving and managing the clinical components of the Start up process from site ID to qualification and site activation.
- Training and management of the CRA team for the lifecycle of project, including: Monitoring visit forecasting/resource management; Adherence to the protocol, SOPs/regulations and project plans; Ensuring data quality and patient safety
- Creates and maintains, in a timely fashion, study specific clinical monitoring plans (CMP) utilizing approved templates ensuring effective communication and escalation instructions are incorporated in the CMP and actioned appropriately
- Ensures the timely completion of all visit reports, reviews them for appropriate content to ensure quality, GCP compliance, finalization within contractual timeline and effective follow up and resolution of site issues
- Plans and drives both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestones
- Apply a risk-based quality management mindset in order to proactively mitigate issues and also provide support for study audits and responses
What we are searching for:
- Bachelor's degree, or local equivalent, in a clinical, biological, scientific, or health-related field
- 5+ years of clinical research/monitoring experience is preferred
- 1+ years of previous Clinical Oversight experience (clinical trial manager) within a Clinical Research Organization
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly.
Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.