FSP Manager Clinical Operations

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Role Overview

This position is fully dedicated to one Client under a Functional Service Provider (FSP) model.

The Clinical Manager is responsible for the line management and functional management of FSP-CRO employees dedicated to the Client. The team may include several roles deployed to a given geographic and/or functional area. The role acts as a leadership role model, the point of escalation for performance and training, and the main FSP-CRO counterpart to the Client's local leadership.

What You'll Do

• •Recruit, onboard and develop staff dedicated to the Client.
• •Ensure all required training is assigned, completed and documented.
• •Provide line management, coaching and mentoring to the team.
• •Manage team performance against Client expectations and KPIs.
• •Evaluate staff monitoring skills through performance assessment visits.
• •Escalate quality, performance and project issues as needed.
• •Manage resource allocation and utilization to meet project needs.
• •Report on team metrics and drive corrective actions where needed.
• •Support the team during audits and inspections.
• •Approve time records and expenses.
• •Contribute to process improvement initiatives.

Education & Experience Requirements

• •Bachelor's degree or equivalent, with a relevant formal academic or vocational qualification.
• •More than 5 years of relevant clinical operations experience, including clinical trial monitoring.
• •2+ year of leadership responsibility.

Years of experience refer to the typical related experience needed to gain the knowledge, skills and abilities to perform the job. They are not the only factor in establishing the job class or making selection decisions.

Knowledge, Skills, Abilities

• •Advanced mentoring, leadership and supervisory skills.
• •Excellent clinical trial monitoring skills, remote and on-site, including risk-based quality management (RBQM).
• •Understanding of, or ability to learn, FSP-CRO and Client SOPs and relevant regulations.
• •Strong data literacy: able to review, interpret and act on data from different systems to drive delivery and performance.
• •Strong critical thinking that considers all elements of the Client partnership.
• •Ability to identify, assess and mitigate risks to project execution and team performance.
• •Ability to drive change and to engage, motivate and influence teams and stakeholders, with a proactive, solution-oriented mindset.
• •Advanced, assertive communication, and the ability to understand co-employment risks.
• •Commitment to ongoing leadership development.
• •Working knowledge of AI tools.
• •Resourcing and capacity management.
• •Professional attitude with strong internal and external customer focus.

Working Conditions and Environment

• •Work is performed in an office environment with exposure to electrical office equipment.
• •Travel to investigator sites may be required to conduct on-site performance assessment visits.
• •Monday-Friday full FTE