Trial Capabilities Manager
Petaling Jaya, Malaysia
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The Trial Capabilities Manager leads the clinical trial capabilities in support of clinical development. The Manager is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out. The manager provides leadership, direction and technical support to the Trial Capabilities Assistant (TCA) in support of clinical development, focusing on results and driving efficiency to achieve goals and objectives. The manager will ensure inspection readiness at all times through a complete, accurate and readily available Trial Master File (TMF) as per defined TMF document ownership.
Clinical Trial Capabilities Responsibilities
- Accountable for meeting and exceeding goals for clinical trial initiation for development programs
- Accountable for ensuring site activation and maintenance activities comply with local/regional requirements, data privacy requirements and Lilly quality standards
- Manage communications/relationships and serve as the point of contact for the trial capabilities deliverable during site initiation, maintenance, and close out representing progress to business partners
- Accountable for prioritization of work to meet portfolio needs
- Ensure flexibility of resources across trial capabilities teams, and geographies (as applicable)
- Ensure inspection readiness through a complete, accurate and readily available Trial Master File
- Strategic prioritization and use of internal clinical trial systems (e.g. IMPACT, Vault Clinical, TrialForce) to allow tracking, performance metrics reporting and to meet regulatory compliance requirements
- Accountable to audit and inspection responses and corrective action plans that under affiliate Trial Capabilities’s responsibilities
- Understand, comply, and reinforce local regulations and guidance, Lilly Medical policies and procedures, and good clinical practices (GCP)
- Identify and ensure shared learning across the Trial Capabilities organization
- Build capabilities in the function through the development and improvement of processes, tools and training and partnering with Clinical Systems and Process Automation to leverage technology to increase efficiency of clinical trial capabilities and resources
- Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning
- Manage staff compliance to local regulations and guidance, Lilly Medical policies and procedures, and good clinical practices (GCP)
People Management and Development
- Recruit, develop, and retain an operationally capable workforce skilled and knowledgeable in clinical development
- 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
Minimum Qualification Requirements
- Bachelor’s degree preferably in a scientific or health related field
- Five (5) years clinical research experience or relevant experience preferred
- Understanding of the overall clinical development paradigm and the importance of efficient site initiation
- Previous supervisory experience
- Strong leadership skills and ability to influence others and lead across the business
- Project management processes and skills
- Appreciation of/experience in compliance-driven environment
- Effective communication, negotiation, and problem-solving skills
- Self-management and organizational skills
- Excellent computer skills
- Language capabilities – English (read, write, conversation)
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-11599.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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