Project Specialist

61 Premier Research Poland Sp. z.o.o; Polska; On-site; PLN 86,000 - 105,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Employee Assistance Program

Job summary

Premier Research Poland is seeking a Project Specialist to join our Business Operations team. You will help biotech, medtech, and specialty pharma companies transform ideas into new medicines, devices, and diagnostics.

The role is offered as a 1-year Fixed Term Contract on Premier Research payroll. The minimum annualized base pay starts at 95,000 PLN, with actual salary influenced by qualifications and proficiency.

Qualifications

• Associate’s degree in life sciences or related field with 2+ years clinical research or a Bachelor’s degree with 1+ year experience in clinical research, healthcare, business, finance, or project management.
• Basic knowledge of ICH/GCP regulations.
• Working knowledge of FDA guidance documents / EU directives / ISO14155 and clinical monitoring procedures.
• Basic knowledge of project management terminology and guidelines.

Responsibilities

• Coordinate and oversee cross-functional project team delivery.
• Facilitate team communications and maintain internal and external documentation.
• Maintain internal and external project team contact lists.
• Schedule meetings, develop agendas, capture minutes, and manage action/decision log.
• Create and distribute study newsletters as required.
• Manage and track budgets related to vendor projects including supplies and invoices.
• Track out of scope services and assist in preparing Change Orders.
• Ensure projects are audit-ready and maintain required project systems and SOP indices.

Skills

ICH/GCP knowledge

FDA/ISO knowledge

PM terminology basics

Education

Associate’s degree in life sciences or related field

Bachelor’s degree or international equivalent

Tools

MS Office

Job description

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.

Job Description

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

This role is offered as a 1 year Fixed Term Contract on Premier Research payroll. Applications should be immediately available or only have a short notice period to be considered.

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.

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

Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. 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.

Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose.

Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.