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
- Recruit, onboard and train (in partnership with R&D Training) new team members to meet current and future program needs
- Provide regular mentoring, coaching and competency development support for all direct reports
- Proactively manage team risks, including attrition and performance challenges.
- Foster a positive team culture, focused on collaboration, open communication, accountability and continuous growth.
- Organize and lead continuous development training sessions where appropriate
Resource Allocation & Program Engagement
- Collaborate with Resource Points of Contact to ensure optimal assignment of team members based on skills, experience, and workload.
- Monitor resourcing needs and proactively address capacity or skill gaps.
- Ensure team members are appropriately prepared for their roles within each assigned program.
Capability Development & Continuous Improvement
- Identify gaps in skills, processes, or tools and implement targeted development or training initiatives.
- Support knowledge sharing across the team to build collective expertise.
- Encourage innovative solutions and best practice adoption to enhance operational effectiveness.
Stakeholder Collaboration
- Serve as the main point of contact for performance escalations related to CSS team members
- Build strong relationships with internal stakeholders to align team development & allocation with the broader needs of the business
Quality & Compliance
- Support the development of team oversight metrics and regularly report progress towards them / swiftly address risks & issues.
- Ensure all team members operate within SOPs, regulatory guidelines and quality standards.
- Support audit & inspection readiness.
Resource Management Support
- Provide support to the SDRM Resource Management team as needed. Support may include management of hiring, allocations and forecasting analysis for in scope roles.
Basic Qualifications and Experience:
- Doctorate degree OR
- Masters degree and 2 years of clinical execution experience OR
- Bachelors degree and 4 years of clinical execution experience OR
- Associates degree and 8 years of clinical execution experience OR High school diploma / GED and 10 years of clinical execution experience
Preferred Qualifications and Experience:
- 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
- Experience managing multiple teams / direct reports across multiple clinical functions
Competencies:
- Ability to manage, mentor, and develop professionals and support staff across functions & geographies, while fostering collaboration across internal and external teams for trial success
- Experience with overseeing study budgets and financial operations, reviewing/approving site expenditures, and optimizing resource allocation to ensure cost efficiencies
- Strong collaboration and communication skills to engage with cross-functional teams, senior management and external stakeholders, internally and externally
- Strong understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles
- Navigates diverse regulatory, cultural, and operational environments. Builds strong relationships across geographies and time zones.
- Ability to identify operational risks based on protocol design and implement innovative mitigation strategies. Identify and manage study issues, communicating and/or escalating appropriately.
- Able to identify and implement opportunities for continuous improvement into the teams working practices
- 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
- 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
