Clinical Trial Leader/Global Clinical Trial Lead - FSP - Oncology Or Inflammation

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health.

From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient.

We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel are currently recruiting for an experienced Global Trial Leader in Germany.

In this role you will be a key member of the clinical delivery team, Nominated to a trial, either an Oncology or Inflammation; phase 3 trial.

CTL’s are accountable for the set-up, execution and delivery of their assigned trial(s) and contribute to delivery of the sponsors 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 is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s.

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.

• Some 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 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 the country allocation and oversees trial feasibility.
• Accountable for development and implementation of trial level engagement plans, recruitment planning and risk mitigation.

Leads 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.

• Prepare and implement amendments of core documents, including training material updates/retraining as needed.
• Support authority/ethics response to requests as applicable.
• Maintain 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 trial medical writer in providing the CTR.
• Responding for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors.
• Support results/documents disclosure of global registries.
• May support 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 team work, to promote high performance teams.
• Experience in either Oncology and or Inflammation.
• Extensive experience in clinical trial project management across international trials
• Masters Degree ideal but not essential.

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