Clinical Trial Lead - single client - Austria, Germany or the UK

Overview

Clinical Trial Lead - single client - Austria, Germany or the UK. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model puts the customer and the patient at the center of everything we do. We collaborate across Functional Service Provider or Full-Service environments to accelerate delivery of therapies.

Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Responsibilities

• Project Leadership and Delivery: Manage a project as a project manager overseeing interdisciplinary clinical research studies, ensuring compliance with GCP, SOPs, and regulatory requirements.
• Serve as primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout per contractual agreement.
• Lead project team to ensure quality, timelines and budget management.
• Be accountable for the financial performance of each project; coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
• Ensure studies are conducted in compliance with GCP, SOPs and regulatory requirements; be accountable for all project deliverables.
• Maintain quality and completeness of TMF for assigned projects.
• Maintain study information across databases and systems.
• Oversee study management components of inspection readiness and develop/implement project plans.
• Plan, coordinate and present at internal and external meetings; prepare project management reports for clients and management.
• Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
• Develop strong relationships with current clients to generate new and/or add-on business for the future.
• May participate in bid defense meetings as potential project manager; may line manage other project management and clinical monitoring staff.

Qualifications

• Bachelor’s Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing or related field.
• Experience in CROs and relevant therapeutic areas; strong knowledge of GCP/ICH and applicable regulatory requirements.
• Experience on pharma or FSP side is essential.
• Strong organizational skills and ability to manage time independently.
• Direct therapeutic area expertise; ability to embrace new technologies.
• Excellent communication, presentation and interpersonal skills, both written and spoken.
• Ability to travel as necessary (approximately 25%).

We are always excited to connect with great talent. This posting is intended for a possible upcoming opportunity rather than a live role. By expressing your interest, you’ll be added to our talent pipeline and considered should this role become available.

About Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.