Clinical Trial Oversight Lead - Northeast & Florida - FSP

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 is seeking a Clinical Trial Oversight lead in any of the following areas: Massachusetts, New York, New Jersey, Pennsylvania, Maryland, Illinois, Ohio or in Florida

Position Purpose:
The Clinical Trial Oversight Lead (CTOL) is responsible for the following:

• Oversight of outsourced monitoring activities to ensure adherence to the protocol, Good Clinical
• Practice (GCP), evolving regulatory requirements and assess monitoring effectiveness.  The CTOL will ensure that the Contract Research Organization (CRO) monitoring is resulting in the effective identification and problem solving of issues.

Organizational Relationships:

• Reports to Functional Service Provider (FSP) Line Management with day-to-day direction from the Client

Primary Responsibilities:

• Conducts oversight visits to assess site performance and CRO effectiveness as directed
• Utilizes a risk-based approach to review critical to quality items at the site level and study level
• Follows Client SOPs and work within Client systems to document oversight activities performed
• Evaluates clinical trial sites to ensure significant site procedures are performed in accordance with the study protocol, applicable study manuals, GCP, and local regulatory requirements
• Troubleshoots and uses alternative and innovative approaches to solve problems impacting clinical site delivery and quality
• Works both independently and collaboratively with cross-functional teams
• Communicates important clinical site assessment information to Clinical team
• May participate in centralized data review/monitoring
• Partners with Client Clinical Operations and Research staff to become knowledgeable on protocol procedures and requirements
• May assist with study-related training of CRO personnel, particularly Clinical Research Associates (CRAs), and study site team members
• Partners with Client and CRO study team members to provide on-site support, answer site questions, and develop custom solutions as needed
• Provides insight to Client and CRO study team on best practices, e.g., implementation of complex protocol processes and procedures identified at high-performing sites
• Remains current with GCP and global regulatory requirements, has a current working knowledge of local/regional regulatory requirements
• Completes assigned training, including general training requirements, Policies, Standard Operating Procedures (SOPs), system, and process-related training
• Adheres to applicable Policies, SOPs, and processes
• Demonstrates commitment to Parexel’s FSP Mission, Vision, and Values, and Parexel’s “We Care” Core Values

Education and Certification:

• Bachelor’s Degree is required.  A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD) is preferred
• 5+ years of relevant experience with 3+ years of direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred

Skills and Experience:

• Risk Based Quality Management experience required
• Proven experience in effectively communicating with site staff including Key Opinion Leaders (KOLs) and thought leaders
• Critical thinker who can review risk signals and apply to oversight activities at the site level
• Experience in all study phases and experience in multiple therapeutic areas
• Previous oversight and regulatory inspection experience preferred
• Risk-based monitoring experience preferred
• Demonstrates flexibility in schedule and wiling to travel frequently in assigned region
• Good organizational skills and ability to deal with competing priorities
• Effective communication skills (written, verbal and presentation)
• Proficient with MS Office Suite (Excel, Word, and PowerPoint)

Language Skills:

• Proficiency in written and spoken English
• Proficient in local language, as applicable
• Fluent in multiple languages and cultural awareness is a plus

Travel Requirements:

• Ability to travel anticipated to be 40-60%