Clinical Monitoring Manager

Essential Functions:

• Collaborate with VP, Global Clinical Monitoring, Regional Head of Clinical Monitoring, and other members of CRA Management and Clinical Project Management on planning, assigning, and directing billable work assignments to CRAs, CMAs and ICRAs to ensure projects are properly resourced and study timelines are met
• Assist in collecting preliminary and follow-up information from clients, with the purpose of identifying and evaluating project feasibility pertaining to clinical monitoring
• Communicate regularly with CRA Management team or staffing provider(s) to ensure adequate staffing and consistent implementation of company policies and procedures
• Assist with defining operational Key Performance Indicators and departmental goals
• Maintain and grow relationships with contract staffing vendors to ensure CTI staffing is adequate
• Manage recruitment process for CRAs (and Consultant/Freelance CRAs as applicable), including review of CVs and conducting interviews collaboratively with Human Resources and others
• Collaborate with other functional areas within CTI to ensure CRA (and Consultant/Freelance CRA as applicable) on-boarding, off-boarding, and project handovers are effective and timely
• Provide Regional Head and/or other members of CRA Management team with regular feedback on issues relating to oversight of performance, addressing complaints, and resolving problems
• Plan and conduct orientation for new CRAs and foster positive attitudes toward project goals
• Coordinate and conduct site training and assessment visits, respectively, and manage sign-off process for CRAs across all project teams to ensure consistency, and identify additional visit needs based on training or QC actions
• Liaise with other departments to assist with identifying, developing, and coordinating delivery of training for CRAs; Work to ensure CTI processes and procedures are being followed and serve as resource in this area
• Coordinate appropriate CRA representation needed for both internal and Sponsor audits
• Liaise with Quality Assurance and assist with SOP writing in accordance with specific areas of activity and/or need to promote continuous improvement through process simplification and harmonization
• Liaise with Quality Assurance for any quality findings or trends identified (e.g. protocol violations, deviations from SOPs or monitoring plans, etc.) and follow-up on any Corrective and Preventive Actions
• Conduct regular meetings to discuss study progress and deliverables, action plans, and assessment of metrics
• Support and manage the professional development/ progressions of CRAs
• Support in evaluation/identification of staff training needs
• Assist in obtaining site feedback on CRA performance to evaluate their level of satisfaction
• Perform any management, business development, invoicing, client management, or company representation

Competencies:

• Knowledge of FDA regulatory requirements and guidelines (i.e., Code of Federal Regulations [CFRs], International Conference of Harmonization [ICH] and GCPs) preferred
• Knowledge of medical and pharmaceutical terminology
• Ability to effectively communicate information both verbally and in writing
• Ability to multi-task, track, and maintain organization in fast-paced, changing environment
• Ability to use good judgment when making decisions
• Ability to provide highest level of customer service
• Ability to build strong bonds to foster open, honest, and candid communication
• Ability to maintain highest level of confidentiality when dealing with proprietary information and sensitive situations
• Ability to effectively use technology and software systems
• Ability to understand basic data processing functions

Required education and experience:

• 3 years clinical research monitoring experience
• Practical experience in conducting clinical studies with pharmaceutical company or Contract Research Organization (CRO)
• Bachelor's degree in allied health fields such as nursing, pharmacy, or health science or equivalent experience as determined by CTI Management and Human Resources
• Management of CRAs within pharmaceutical company or CRO

WORK ENVIRONMENT

• This job generally operates in a professional office environment.

TRAVEL

• Domestic and international travel required

OPPORTUNITIES

• Tasks, duties, and responsibilities as listed in this job description are not exhaustive.