Study Delivery Lead (FSP)

Homebased - East/West Europe.

Everything we do has the potential to impact patient lives, and our Study Delivery Leads (SDL) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client, and site satisfaction.

As an SDL at Parexel, you will be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

The Vaccines/Covid Supported Studies Delivery Lead is responsible/ accountable for the set-up, coordination, and delivery of Investigator Sponsored (ISS) and Supported Collaborative Studies (SCS) from the Vaccines area, specifically:

· Proactively managing end to end study delivery for ISS and/or SCS, providing operational support for delivery of assigned studies ensuring they are conducted in accordance to SOPs, relevant legislation, on time and within budget from concept to completion.

· Operational point of contact for the external Study Sponsor and Internal Stakeholders:

· Working with the supplies team/s to manage commercial and clinical supplies.

· Working with the finance team/s to effectively forecast budget, track invoicing/payments and track actual spend.

· Partnering to complete contracting activities such as due diligence and ABAC checks.

· Study timeline and milestone management.

· Manage end to end KPI reporting internally on individual study status.

· Review proposals and protocols for operational feasibility.

QualificationsWe are looking for professionals with these required skills to achieve our goals:

· Bachelor's degree in Life Sciences or related field.

· Minimum of 3+ years’ experience in clinical operations plus Lead CRA or Project Lead experience.

· Experience of working in academic partnerships and/or external alliances with proven clinical project or alliance management skills.

If you have the following characteristics, it would be a plus:

· Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience.

· Experience of vaccines Drug Development.

· Experience in Investigator-Initiated Research.

About Parexel FSP:

A global provider of functional service solutions across a range of specialized disciplines for clinical development and biopharmaceutical product lifecycle support including clinical operations, biometrics, safety, regulatory, medical writing, and medical affairs.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.