Study Start-Up Leader at Parexel, Bachelor’s Degree in Life Science -Apply now!

Study Start-Up Leader at Parexel, Bachelor’s degree in life science -Apply now!

Welcome to Parexel, a leading global biopharmaceutical services company dedicated to driving the development of innovative therapies and improving patient health worldwide. We are currently seeking a highly motivated and experienced Study Start-Up Leader to play a pivotal role in the strategic execution and planning of our clinical trials. If you have a strong background in clinical research and a passion for accelerating the study start-up process, we encourage you to apply!

Role Overview

Job ID: R0000031382 Category: Clinical Trials

About This Role

Job Purpose: As a Study Start-Up Leader (with potential for Associate or Senior level depending on experience), you will be directly accountable for the meticulous execution of our study start-up strategy and comprehensive planning. This encompasses the effective management and seamless coordination of critical start-up activities. Your responsibilities will include ensuring strict alignment with country-specific regulations, managing the efficient collection and approval of Core and Site documents, overseeing the customization and approval of Informed Consent Forms (ICF), facilitating timely submissions to Ethics Committees (EC) and Regulatory Authorities/Ministries of Health (RA/MoH), expertly scheduling Site Initiation Visits (SIVs), and diligently managing all site activation requirements.

For those

with more extensive experience, the Senior Study Start-Up Leader will assume the role of a study-level program lead. In this capacity, you will manage the delivery of multiple protocols for a specific Sponsor or across an entire asset development program. Furthermore, you will be the go-to expert, providing in-depth knowledge and guidance on agreed-upon partnership processes.

Key Accountabilities

• Strategically manage the entire study start-up process from initiation to completion.
• Develop and implement robust site activation strategies to ensure timely study commencement.
• Oversee start-up delivery and governance, ensuring adherence to timelines and quality standards.
• Expertly coordinate and clearly articulate critical path planning for all essential start-up activities.
• Implement critical path planning effectively within Site Initiation Scheduling, System Set-up, Essential Document List (EDL) Management, EC & RA/MoH Strategy development, ICF Customization, Risk Mitigation strategies, Monitoring Plan development, Site Activation Requirements management, and the utilization of relevant tools.

Knowledge and Experience

• Demonstrable client-facing experience within the healthcare sector, clinical research field, project management, or a contract research organization (CRO).
• Proven ability to thrive and succeed within a multi-national organization.
• Prior Project Management experience is highly preferable.
• Comprehensive end-to-end study start-up experience and in-depth expertise are strongly preferred.
• Excellent written and oral communication skills in English are essential.

Education

• A Bachelor’s degree in a life science discipline or equivalent relevant clinical trial experience, particularly focused on study start-up activities, is required. An advanced degree is preferable.

CLICK HERE TO APPLY ONLINE

Keywords: Study Start-Up Leader, Clinical Trials, Healthcare, Clinical Research, Project Management, Contract Research Organization,Study Start-Up Leader at Parexel. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.