Site and Monitoring Health Lead

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.

Key Responsibilities:

Implement clients Site and Monitoring Health strategy in alignment with ICH GCP E6 and E8

Employ risk-based thinking to focus on what is critical to quality and exhibit an inspection ready at all times mentality

Create Study Specific Oversight Plans (SSOP) for aligned trials in scope and/or follow SSOP when conducting oversight activities

Implement various types of oversight encounters and activities as applicable including but not limited to: site risk analysis site contacts aggregate review of data monitoring visit report review Sponsor Oversight Visits system/data spot checks and periodic summaries; ensure timely documentation of these activities is completed and filed

Build relationships with investigators and site staff in region; act as a resource for identifying potential sites for new studies

Utilize root cause analysis to assess identified issues and provide suggested actions to Study Management / CRO to mitigate risk

Support investigator sites less experienced in research; assist in assuring sites are engaged in the study and have what they need to recruit participants successfully

Troubleshoot and use alternative and innovative approaches to solve problems impacting clinical site delivery and quality

Work closely with Clinical Risk & Analytics staff to understand the risk management plan (Risk MAP) for assigned studies ensure the SSOP is aligned with the Risk MAP and assess sites who are outliers

Lead oversight and trend meetings with the study team and/or CRO to discuss risks issues and trends identified by the SMH team for the trial

Complete Sponsor Oversight Visit reports consistently on time and with good quality

Work independently and collaboratively with cross-functional teams

Support inspection preparation and management

Maintain awareness of changes in industry and regulatory standards for GCP requirements

Travel on assignment 50% is required. This is a site facing position and travel may fluctuate up or down depending on business need. May include local regional and international travel.

Requirements

Bachelors Degree is required. A clinical or advanced degree (RN MPH MS MA MBA PharmD) is preferred

Previous direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred

Experience in all study phases of clinical research (Phase I-III) and experience in both prevalent and rare medical conditions preferred

Previous audit and regulatory inspection experience preferred

Comprehensive and current regulatory knowledge including GCPs

Skills

Demonstrate flexibility in schedule and willingness to travel frequently in assigned region

Excellent interpersonal verbal and written communication skills

Fluency in multiple languages and cultural awareness is a plus

Ability to build and maintain relationships with key investigators and sites (e.g. key networks key trial sites and investigators key opinion leaders and their site staff

Innovator willing to initiate changes introduce new ideas and creatively problem-solve

Experience with Microsoft based applications and ability to learn internal and external computer systems

Good organizational skills and ability to deal with competing priorities

Analyze complex situations and effectively communicate issues along with potential recommendations to various functional groups

Demonstrate good judgment and decision-making experience