Project Specialist

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.

About Premier Research

• 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.

Responsibilities

• 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

Requirements

• 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
• This role is offered as a 1 year
• Applications should be immediately available or only have a short notice period to be considered.

Pay

• Fixed Term Contract on Premier Research payroll.
• Premier Research is dedicated to providing compensation that is fair and competitive with market standards.
• The minimum annualized starting base pay for this role is 95,000 PLN.
• The actual salary will be influenced based on a variety of factors such as qualifications, skills, competencies, and proficiency for the role.

Benefits

• We also offer comprehensive benefits packages, which may include health insurance, life insurance, retirement plan, paid time off, and an Employee Assistance Program.