Manager, Clinical Monitoring (In-House CRA)

The Manager, Clinical Monitoring is responsible for oversight of all activities related to clinical monitoring, including resource management, assurance of quality data and deliverables, and the development and growth of clinical monitoring staff.

Responsibilities:

• Acts as a subject matter expert in Clinical Monitoring
• Provides leadership and mentorship for assigned Clinical Monitoring staff
• Manages Clinical Monitoring employee performance and career development
• Manages Clinical Monitoring team resourcing by working with Project Management and other functional areas
• Assists with development of monitoring strategies
• Drives continuous development and training for clinical monitoring staff, including developing training material and training staff to applicable SOPs, regulations, requirements, and standards
• Drives a culture of continuous process improvement
• Hosts one-on-one meetings and performs employee evaluations
• Manages, maintains and oversees Clinical Monitoring metrics
• Performs CRA assessment visits and develops performance improvement plans as needed
• Liaises with project management to ensure CRAs are fulfilling monitoring requirements and meeting project and client deliverables and timelines
• Assists with CRA, Sr. CRA or LCRA/CTL project team member transitions
• Attends project team calls to support deliverables of a project
• Leads operational initiatives
• Interviews qualified candidates and ensures proper on-boarding to the Clinical Monitoring Department
• Attends Capabilities Meetings, Bid Defense Meetings and Kick-off Meetings as needed as a monitoring subject matter expert

Qualifications:

• Minimum requirement of a Bachelor's degree in biological sciences, healthcare, pharmacy, or nursing; MBA/MHA, MS/MSc. or PhD preferred
• Member of ACRP/ICR/SoCRA preferred
• 3 years of direct CRA (Line) Management experience or managing clinical teams in Pharma or CRO environment
• 2 years CRA level experience (both CRO and industry experience are acceptable)
• Strong Leadership skills including excellent verbal and written communication, and presentation skills
• Excellent interpersonal and organizational skills with attention to detail
• Strong computer proficiency in MS Office including Outlook, Word, Excel, and PowerPoint;
• Global clinical trial experience preferred
• Ability to work well in a team environment but also independently without significant oversight;
• Flexibility in work hours and ability to travel
• Must be fluent in English and in the languages of the regions/territories that are assigned

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.