Premier Research is looking for a Project Specialist to join our Business Operations 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 Biotech™. Join us and build your future here.What You'll Be Doing - Partners with the Project Manager (PM) to ensure overall successful Project Delivery through coordination and oversight of the cross-functional project team (including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety)
- Responsible for facilitating and collecting information as it pertains to team and functional department deliverables and milestones through clear communication with the functional leads and use of various study databases and maintaining documentation internally and externally
- Identifies risks associated with milestones and deliverables and ensures project TMFs are audit ready. Documentation of risks are logged and resolved with cross-functional teams
- Maintains internal and external project team contact lists, system access requests, and e-mail distribution lists. Ensures effective communication by scheduling internal and external team meetings, developing agendas, capturing minutes, and managing the action/decision log. Creates and distributes study newsletters as required
- Manage and track budgets related to vendor projects including tracking of supplies and invoices and track out of scope services and assists in preparing Change Orders
- Collaborates with the functional leads in the development of team trainings or meeting presentations and maintains the study training matrix. Ensures completion and proper documentation of study specific training requirements as directed by the PM
What We Are Searching For - Associates Degree (or international equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field plus 2+ years clinical research experience
- Bachelor's Degree (or international equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field and a minimum of 1 year of professional work experience in clinical research, healthcare, business, finance, and/or project management preferred
- Basic knowledge of ICH/GCP regulations
- Working knowledge of FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
- Basic knowledge of project management terminology and guidelines
- Strong computer skills in MS office suite required
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
