[Hiring] Clinical Trial Leader/Global Clinical Trial Lead @Parexel

Role Description

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.

• Accountable for the set-up, execution and delivery of their assigned trial(s).
• Contribute to delivery of the sponsors pipeline through accurate planning and efficient execution of trials.
• Provide leadership and direction to the trial team.
• Accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s.
• Responsible for managing the planning, implementation and tracking of the clinical trial processes as well as risk mitigation.
• Liaise closely with the CTM on all study related issues.
• Communicate 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.
• 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.
• Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements.
• 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.
• Ensures timely cleaning and delivery of clinical trial data.
• Coordinates and supports trial medical writer in providing the CTR.
• Responsible for timely, complete and compliant archiving of all relevant global documents in the TMF.
• Support results/documents disclosure of global registries.
• May support publication of trial data.

Qualifications

• 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 and/or Inflammation.
• Extensive experience in clinical trial project management across international trials.
• Masters Degree ideal but not essential.

Benefits

• Join Our Talent Community and we’ll reach out with job alerts when positions that match your career interests become available.
• Periodic updates about the latest company news and events.