Premier Research is looking for a Senior Trial Manager to join our Functional Services (sponsor-embedded) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechTM. Join us and build your future here.
What You’ll Be Doing:
Provides oversight and trial management of the planning, execution, and completion of clinical trials in accordance with all applicable regulations and guidance including ICH/GCP
Ensures successful management and coordination of all members of the trial operations team, to support milestone achievement and overall project delivery
- Provides clinical operations oversight in the evaluation and selection of investigative sites and vendors (e.g. – central labs, IVRS, etc.), and drives the successful activation of trial sites according to time, quality/scope, and budget parameters
- Oversees study finance management that may include budget review, change orders, reconciling of forecast/actual variance, allocation of FTE, productivity oversight, etc.
- Facilitates the development and review of project documentation, such as Case Report Forms, Source Documents, templates and study plans. May contribute to the review of protocol/study design, informed consent forms, and be a reference point for CRAs and investigative sites
- Manages recruiting efforts and activities to meet study enrollment goals, overseeing both patient recruitment and retention together with other functional leads in order to meet project milestones
You'll need this to be considered:
- Bachelor’s degree, or its international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field; or equivalent combination of education, training, and experience
- Must have clinical/study oversight experience and onsite clinical monitoring experience. 9+ years of study management, global trial oversight, study finance, CNS, and FSP experience highly preferred.
- Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
- Demonstrates excellent English verbal and written communication skills
- Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
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 Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, 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.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
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.
