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 here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What you’ll be doing:
- Partners with the Project Manager (PM) to ensure overall Project Delivery through coordination and oversight of the cross-functional project team
- Responsible for facilitating team communications and maintaining documentation internally and externally. Maintains internal and external project team contact 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. Track out of scope services and assists in preparing Change Orders.
- Tracks supplies, invoices, and budgets relating to vendor management, as appropriate.
- Ensures projects are audit ready
- Creates and manages the required project systems, SOP indices, and study team lists, as applicable. Manages study team/contact lists, system access requests, and e-mail distribution lists as required
What we are searching for:
- Associate’s degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field and a minimum of 2 years of clinical research experience or a Bachelor’s degree, or international equivalent, preferably in a clinical, biological, scientific, business, or health-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
