ABOUT THE ROLE
Role Description:
The Manager, CSS is accountable for hiring, managing, mentoring and growing a team of Study Delivery Associates and Sr Associates. The role is accountable for continually developing the CSS roles within their team, ensuring they are positioned to deliver high-quality operational support to clinical programs and managing performance issues effectively and compassionately.
Roles Responsibilities:
Team Management
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Recruit, onboard and train (in partnership with RD Training) new team members to meet current and future program needs
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Provide regular mentoring, coaching and competency development support for all direct reports
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Proactively manage team risks, including attrition and performance challenges.
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Foster a positive team culture, focused on collaboration, open communication, accountability and continuous growth.
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Organize and lead continuous development training sessions where appropriate
Resource Allocation Program Engagement
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Collaborate with Resource Points of Contact to ensure optimal assignment of team members based on skills, experience, and workload.
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Monitor resourcing needs and proactively address capacity or skill gaps.
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Ensure team members are appropriately prepared for their roles within each assigned program.
Capability Development Continuous Improvement
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Identify gaps in skills, processes, or tools and implement targeted development or training initiatives.
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Support knowledge sharing across the team to build collective expertise.
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Encourage innovative solutions and best practice adoption to enhance operational effectiveness.
Stakeholder Collaboration
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Serve as the main point of contact for performance escalations related to CSS team members
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Build strong relationships with internal stakeholders to align team development allocation with the broader needs of the business
Quality Compliance
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Support the development of team oversight metrics and regularly report progress towards them / swiftly address risks issues.
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Ensure all team members operate within SOPs, regulatory guidelines and quality standards.
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Support audit inspection readiness.
Resource Management Support
Basic Qualifications and Experience:
Preferred Qualifications and Experience:
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5 years work experience in life sciences industry, particularly focusing on clinical trial work, including 3 years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company
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Experience managing multiple teams / direct reports across multiple clinical functions
Competencies:
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Ability to manage, mentor, and develop professionals and support staff across functions geographies, while fostering collaboration across internal and external teams for trial success
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Experience with overseeing study budgets and financial operations, reviewing/approving site expenditures, and optimizing resource allocation to ensure cost efficiencies
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Strong collaboration and communication skills to engage with cross-functional teams, senior management and external stakeholders, internally and externally
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Strong understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles
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Navigates diverse regulatory, cultural, and operational environments. Builds strong relationships across geographies and time zones.
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Ability to identify operational risks based on protocol design and implement innovative mitigation strategies. Identify and manage study issues, communicating and/or escalating appropriately.
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Able to identify and implement opportunities for continuous improvement into the teams working practices
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Clear understanding of risk-based site monitoring ensuring regulatory compliance and timely implementation of Corrective and Preventive Actions (CAPA) to mitigate risks, resolve operational challenges and ensure inspection readiness
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Experience with developing and training teams related to clinical trial materials (e.eg., CRAs, site staff, and cross-functional teams) to ensure alignment with study protocols, regulatory requirements, and best practices
