Global Clinical Trial Leader - Sponsor Dedicated

Job Description

As a part of the global Project Leadership group at Parexel, you are responsible for leading cross-functional teams to deliver high-quality and patient-focused clinical trials and help bring life-changing treatments to market faster. You collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets. The role requires strong leadership and communication skills, the ability to work under pressure, and a passion for improving patients' lives. In return, Parexel offers a supportive work environment, and a high degree of empowerment and accountability to lead your studies. Within this role, you work with a diverse set of clients and therapeutic areas, and you are encouraged to take on new challenges and pursue your interests.

Job Responsibility

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
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

Requirements

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, CNS, Immunology or Vaccines
Extensive experience in clinical trial project management across international trials
Masters Degree ideal but not essential

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Global Clinical Trial Leader - Sponsor Dedicated - Home Based

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