Clinical Trial Leader/Global Clinical Trial Lead - FSP

Global Clinical Trial Lead - FSP

Parexel is currently recruiting an experienced Global Trial Leader in Germany.

In this role, you will be a key member of the clinical delivery team, nominated to a specific trial. CTLs are accountable for the set-up, execution, and delivery of their assigned trial(s) and contribute to the delivery of the sponsor's pipeline through accurate planning and efficient execution of trials that bring speed and value to participating subjects and sites.

As the CTL, you'll provide leadership and direction to the trial team and are accountable for the overall success and delivery of your assigned clinical trial according to defined milestones and KPIs.

The CTL is responsible for managing the planning, implementation, and tracking of the clinical trial processes, as well as risk mitigation. The CTL serves as a proactive member of the Clinical Delivery Team, liaising closely with the CTM on all study-related issues. As Lead of the Trial Team, the CTL communicates trial status to all shareholders.

This will be a fully remote, home-based position.

Specifics About This Advertised Role

• Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track. Supports the development of trial-level documents owned by other functions (e.g., Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring).
• Verifies and provides input into country allocation and oversees trial feasibility.
• Accountable for the development and implementation of trial-level engagement plans, recruitment planning, and risk mitigation. Leads the development of core trial and patient-facing documents. Integrates.
• Maintains oversight during clinical trial conduct, including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation. In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management, and safety reporting.
• Prepares and implements amendments of core documents, including training material updates/retraining as needed.
• Supports authority/ethics response to requests as applicable.
• Maintains oversight of outsourcing of vendor services (including Central Lab) in conjunction with other functions.
• In collaboration with other functions, ensures timely cleaning and delivery of clinical trial data. Coordinates and supports the Trial Medical Writer in providing the CTR.
• Responsible for timely, complete, and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors.
• Supports results/documents disclosure of global registries.
• May support the publication of trial data.

Who are Parexel?

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today's top 50 best-selling drugs, but equally, we enable more niche drug developments that are critical to the well-being of many patients. You'll be an influential member of the wider team.

What We Are Looking For in This Role

• Minimum of 5 years of relevant clinical trial management experience.
• Strong clinical trial project management experience.
• In-depth understanding of project management with an emphasis on teamwork, to promote high-performance teams.
• Experience in either Oncology, CNS, Immunology, or Vaccines.
• Extensive experience in clinical trial project management across international trials.
• Master's Degree ideal but not essential.

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.