Line Manager, Clinical Monitoring

The Line Manager, Clinical Monitoring FSS (LMCM) is responsible for oversight of all activities related to clinical monitoring as they pertain to a specific client and/or Functional Service Provider (FSP) program. As part of the dedicated client FSP team, the LMCM's responsibilities include but are not limited to resource management, assurance of quality data, and deliverables, as well as the development and growth of the clinical monitoring staff.

The Line Manager, Clinical Monitoring is responsible for performance management of CSAs and Lead CSAs for an assigned client and ensuring the standardization, consistency and adherence of Site Management departmental responsibilities across the clinical studies. This includes all activities conducted by Lead/CSAs including feasibility, study-start-up, site management/monitoring activities; in addition to resource management, assurance of quality data and deliverables, and the development and growth of CSA staff.

Responsibilities:

• Acts as a subject matter expert for the Lead CSA and CSA roles
• Provides leadership and mentorship for assigned Lead/CSA staff
• Manages Lead/CSA performance and career development
• Manages Lead/CSA team resourcing by working with the FSP Program Manager and Site Management Directors
• Assists with study feasibility in assigned regions, as needed
• Assists GSSU with study-start up activities, as needed in conjunction with assigned Lead/CSAs, acts as back-up.
• Drives continuous development and training for Lead/CSA staff, including developing training material and training staff to applicable SOPs, regulations, requirements, and standards
• Hosts one-on-one meetings and performs employee evaluations
• Manages, maintains and oversees Site Management metrics
• Performs Lead/CSA assessment visits and develops performance improvement plans as needed Liaises with Global Clinical Development and applicable Study Execution Team (SET) members to ensure Lead/CSAs are fulfilling requirements and meeting project and client deliverables and timelines
• Assists with Lead/CSA study team member transitions
• Attends study team calls to support deliverables of a project, as needed
• Interviews qualified candidates and ensures proper on-boarding to the Lead/CSAs
• Manages training requirement completion by Leads/CSAs

Qualifications:

• A degree (BSc/MSc or equivalent) in life science, nursing, pharmacy, medical laboratory technology or other health/medical related area preferred. Other degrees and certificates considered if commensurate with related clinical research experience (e.g., diploma or associate RN, certified medical technologist)
• A minimum of 3 years of direct CRA (Line) Management experience or managing clinical teams in Pharma or CRO environment
• A minimum of 2 years of additional on-site monitoring 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.