Clinical Trial Leader

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.

 Trial Preparation 

• 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 patient/site level feedback during document development and ensures trials are designed with a focus on patient value  

• Ensures activities are frontloaded where possible at the trial level and cascaded to country level to facilitate efficiencies as well as to ensure and leverage speed 

• Oversees outsourcing of vendor services in conjunction with other functions; supports identification of vendors, vendor selection and development of vendor scope of work 

• Works with functional partners to ensure that all required trial processes are in place to meet trial delivery milestones (e.g. clinical quality monitoring, safety monitoring and reporting, investigational medicinal product, trial budget, site monitoring) 

• Aligns and supports team members in timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders  

• Provides/supports provision of appropriate study- specific and standardized non-trial specific trial team training, internal and external partners 

Trial Conduct 

• 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, Safety Management Committee (SMC)/Data Management Committee (DMC) management and safety reporting 

• Prepare and implement amendments of core documents including training material updates/retraining as needed 

• Support authority/ethics responses to requests as applicable 

• Maintains oversight of outsourcing of vendor services (including central lab) in conjunction with other functions 

• Monitor progress of patient recruitment and accrual of endpoints and proactively update and action contingencies throughout trial conduct. 

• For early clinical trials, co-ordinates and harmonizes Innovation Unit tasks in a trial (e.g. biomarker sampling, genomics, sub-studies) 

Trial Closeout and Reporting 

• In collaboration with other functions, ensures timely cleaning and delivery of clinical trial data 

• Coordinates and supports Trial Medical Writer in providing the Clinical Trial Report (CTR) 

• Responsible for timely, complete, and compliant archiving of all relevant global documents in the TMF, including all require documents from vendors. 

• Support results/documents discl