Support managers in addressing complex performance or resourcing challenges.
Promote a culture of accountability, transparency, quality and continuous learning across all levels.
Resource Planning & Program Engagement
Oversee resource allocation across Managers’ teams ensuring optimal alignment with program requirements.
Anticipate resourcing risks and pro-actively develop & execute effective mitigation plans.
Anticipate resourcing needs and partner with Talent Acquisition for timely hiring and succession planning.
Stakeholder Collaboration & Communication
Build strong trust-based relationships with key stakeholders and act as the senior operational contact for escalations involving centralized study support teams,
Communicate succinct, effective functional updates, priorities, risks and successes to Director, SDRM
Quality & Compliance
Ensure all team members operate within SOPs, regulatory guidelines and quality standards.
Capability Building & Continuous Improvement
Identify organizational skill gaps and develop a cohesive capability building strategy in partnership with Sr Mgr, CSS colleagues.
Lead initiatives to enhance processes, tools and systems that improve the quality, efficiency and consistency of CSS (pro-actively leveraging AI and other automation opportunities where appropriate).
Resource Management Support
Provide support to the SDRM team as needed. Support may include management of hiring, allocations and forecasting analysis for in scope roles.
Basic Qualifications and Experience
Doctorate degree and 2 years of clinical execution experience OR
Master’s degree and 6 years of clinical execution experience OR
Bachelor’s degree and 8 years of clinical execution experience OR
Associate’s degree and 10 years of clinical execution experience OR
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications and Experience
12+ years work experience in life sciences industry, particularly focusing on clinical trial work, including 5 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 identify operational risks based on protocol design and implement innovative mitigation strategies. Identify and manage study issues, communicating and/or escalating appropriately.
Strong collaboration and communication skills to engage with cross-functional teams, senior management and external stakeholders, internally and externally
Interprets clinical and operational data to guide trial execution and identify study trends. Collaborates with biostatistics and data management to ensure data integrity
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
Able to identify and implement opportunities for continuous improvement into the team’s working practices
Strong understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles
Experience with overseeing external vendors (Contract Research Organizations, labs, imaging vendors, etc.) to drive and meet study deliverables with high quality
Navigates diverse regulatory, cultural, and operational environments. Builds strong relationships across geographies and time zones.
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
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