Job Description

Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

We are currently looking for anInitiation Clinical Research Associate I for the EMEA Centralized reviewers' team acrossto be based in Serbia. This role focuses on ICF preparation (customization) and on reviews of ICF and SRP.

Through your work in this role you will:

Become a part of the international growing team, supporting core Parexel business and key clients who stand behind the key breakthrough therapies

Support all countries in EMEA region (and some countries from other regions as well), with focus on key countries like Germany

Be a part of one of the core teams supporting the implementation of new and long awaited way of performing clinical trials start-up in Parexel: harmonized and centralized submission of studies via Clinical Trials Information System (CTIS) based on the new EU-CTR (Regulation no 536/2014) that is finally coming in force from 31 January 2022

Have the chance to develop, the be SME for key client accounts, or for countries and also coaches in terms of specialized systems that we used (Veeva)

Be part of the group with high team spirit and mutual support

Role Responsibilities

Customize, review as needed, country/site specific Informed Consent Forms (ICF)

Customize any ICF amendments

Review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable

Ensure timely and accurate completion of project goals and update of
applicable trial management systems.

Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.

Show commitment and perform consistent high quality work.

Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s)
in an open, balanced, objective manner, modeling the high performance culture values.

Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs,
other Parexel / Sponsor training requirements and study specific procedures, plans and training.

Ensure basic understanding of milestones and strive for high quality, timely, and efficient delivery.

Provide input and feedback for Performance Development Conversation(s).

Proactively keep manager informed about work progress and any issues.

Develop expertise to become a subject matter expert.

Work in a self-driven capacity, with limited need for oversight

Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)

Qualifications

Key Skills

English language proficiency

Medical or pharmacy and similar science education background is a benefit but not a must

Experience with pharma business (both CRO or pharma companies) is a benefit but not a must

Technical skills - working with systems - is beneficial

Desire to work with documents, attention to detail, skilled/ willing to learn to work with many new exciting systems

Able to organize work efficiently, able to multitask and in parallel be able to prioritize as needed (in consultation with LM as needed)

Strong communication skills

Willingness to learn new things, be flexible, open-minded, able to work under some stress (has some strategy to cope)

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.