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Job Description
Senior Manager Trial Capabilities, Budgets and Contracts
Lead the clinical trial capabilities budgets & contracts in support of clinical development, responsible for site budgeting and contracting during site activation, management and closeout, clinical finance, records management, training, and trial metrics across all therapeutic areas.
About the Role
- Accountable for meeting and exceeding goals for clinical trial initiation for development programs in the region of responsibility.
- Ensure site initiation and maintenance activities comply with local/regional requirements, data privacy requirements and Lilly quality standards.
- Drive and ensure Budgets and Contracts Site Activation strategies are created and delivered.
- Manage communications/relationships and serve as the point of contact for the trial capabilities deliverable representing progress to business partners internally and externally.
- Support global solutions across geographic regions and in conjunction with other clinical development and MDU functions.
- Accountable for prioritisation of work to meet portfolio needs.
- Ensure flexibility of resources across budgets and contracts trial capabilities teams and geographies.
- Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements.
- Develop and manage strategies to improve customer experience.
- Ensure inspection readiness through a complete, accurate and readily available Trial Master File.
Responsibilities
- Clinical Trial Capabilities Responsibilities
- Accountable for meeting and exceeding goals for clinical trial initiation for development programs in the region of responsibility.
- Accountable for ensuring site initiation and maintenance activities comply with local/regional requirements, data privacy requirements and Lilly quality standards.
- Drive and ensure Budgets and Contracts Site Activation strategies are created and delivered.
- Manage communications/relationships and serve as the point of contact for the trial capabilities deliverable representing progress to business partners internally and externally.
- Support global solutions across geographic regions and in conjunction with other clinical development and MDU functions.
- Accountable for prioritisation of work to meet portfolio needs.
- Ensure flexibility of resources across budgets and contracts trial capabilities teams and geographies.
- Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements.
- Develop and manage strategies to improve customer experience.
- Ensure inspection readiness through a complete, accurate and readily available Trial Master File.
- Organizational Leadership
- Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within the CDO and MDU.
- Build capabilities in the function through the development and improvement of processes, tools and training and partnering with Trial Capabilities, Budgets & Contracts, System and Technology to leverage technology to increase efficiency of budgets and contracts clinical trial capabilities and resources.
- Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning.
People Management and Development
- Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in clinical development and budgets and contracts.
- Effectively manage an agile organization that continuously meets the needs of a changing portfolio.
- Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment based decision making in clinical delivery.
Qualification Requirements:
- Bachelor's degree, and five years clinical research experience preferably in budget and contract field.
- Understanding of the overall clinical development paradigm, budgeting and contracting process, and the importance of budget and contract role in efficient site initiation.
- Previous industry related supervisory or leadership experience.
- Strong leadership skills and ability to influence others and lead across the business.
- Advanced project management skills.
- Experience in compliance-driven environment.
- Ability to learn and comply with financial and legal guidelines and policies (budget and contract).
- Effective communication, negotiation, and problem solving skills.
- Self-management and organizational skills.
- Language capabilities preferred.