Local Trial Manager - Neuroscience And Immunology (Home-Based)

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Who are we?
We Are PRA.
We are 20,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. ResponsibilitiesWhat will you be doing?
Working outsourced and fully dedicated to one of our global pharmaceutical clients, the Local Trial Manager is responsible for the successful management and execution of study activities at a country level. Collaborating with the wider global study team, the Local Trial Manager leads the local team of Site Managers and Clinical Trial Assistants in order to deliver quality data and trial documents that are compliant with protocol, ICH-GCP guidelines, Standard Operating Procedures and regulatory requirements.
Key Tasks Include (But Not Limited To):

• Managing the local team to meet recruitment targets
• The efficient management of local vendors
• Timely review of trip reports submitted by Site Managers
• Targeted and effective study team training
• Preparation for audits
• Development of local study tools and procedures
• Proactive risk management and budget forecasting
• Accompanying Site Managers on on-site visits to ensure protocol compliance at a site level, and to foster positive working relationships with site staff, including Investigators
• Some on-site monitoring of assigned sites
• Managing studies from feasibility through to database lock and close-out, the Local Trial Manager acts as the key local manager throughout the lifecycle of the project

QualificationsWhat do you need to have?

• 
  A minimum of a 4-year Bachelor’s degree or relevant clinical experience is required
• Minimum 4 or more years of pharmaceutical and/or clinical trial experience is preferred.
• Experience with clinical trial management is required
• Solid understanding of the drug development process including ICH/GCP and local regulatory requirements.
• Solid communication and computer skills required.
• Proficient in speaking and writing the country language and English language.
• Good written and oral communication skills.
• Willingness to travel with occasional/regular overnight stay away from home depending on the region.
• Flexible mindset and ability to work at a fast pace within small exploratory study teams.
• Ability to work on multiple trials in parallel in different disease areas.
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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