At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 

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Job Overview

Responsible for activities that support the clinical trial process from start-up to close out. Clinical Operation professionals are tasked with the planning, implementation, management, and execution of the clinical trial process.

Team Management

Lead, mentor, develop, and manage Clinical Operations Teams, including Clinical Trial Assistants and Clinical Operations Specialists, ensuring optimal team performance and development. Strategically allocate resources across clinical studies, ensuring optimal use of Clinical Trial Assistants and Clinical Operations Specialists based on study demands and timelines. Manage and oversee study start-up activities, ensuring smooth and timely execution of contracts, budgets, and IRB submissions. May work with corporate legal teams as necessary. Monitor project plans, tracking the time required for various clinical tasks to ensure accurate forecasting and resource assignment. Manage tools used throughout the clinical research organization to assess resource load forecasting and utilization of all teams. Ensure the site and lab invoicing process is accurate, timely, and in accordance with contractual agreements. Participate in company initiatives, policies/procedures, continuous improvement initiatives, and share knowledge where applicable. Lead biweekly department team meetings. Help create a fun, rewarding, and collaborative environment.

Clinical Trial Management System (CTMS)

Oversee the CTMS, including management of system configuration changes to support evolving study and business needs, ensuring adherence to established change control processes. Collaborate with cross-functional teams to set up templates within reports and adjust the eTMF structure within the CTMS to ensure documentation is consistently accurate and audit-ready. Collaborate with cross-functional teams to ensure study-specific completeness and accuracy throughout the trial lifecycle, maintaining data integrity, and facilitating effective study tracking and reporting, including archival of documents and data. Conduct trainings for the department on new processes, tools, and updates within the CTMS, ensuring alignment with business needs and system capabilities. Create and implement best practices for process improvement and tool usage, enhancing team efficiency and system utilization. Manage billing for CTMS usage, ensuring accurate tracking of system costs and invoicing, and work with finance teams to reconcile expenses related to the CTMS.

Trial Master File (TMF) Management

Oversee eTMF setup, ongoing quality review, and final reconciliation. Develop and implement TMF processes and procedures, along with TMF-related training materials that adhere to regulatory requirements and industry best practices. Act as subject matter expert for TMF operations and requirements. Stay informed of regulatory changes and industry best practices related to TMF operations and coordinate with stakeholders to implement continuous operational excellence.

Compliance and Quality Assurance

Work with global quality, regulatory assurance, and CRO leadership to analyze process workflows, update, and maintain Work Instructions, Standard Operating Procedures (SOPs), and other operational documents to ensure compliance with GCP regulations and company policies. Act as CRO lead for both internal and external audits. Support quality teams with DCO processing as necessary. What your background should look like: Bachelor’s Degree with a minimum of 5 years of clinical experience at a biotech, pharmaceutical company, site, or clinical CRO                                                      Previous supervisory/line management experience preferred. Experience leading project operational teams through all stages of the trial (forecasting/planning, start-up, conduct, close-out). Previous monitoring, study coordination, data management and/or clinical project management experience, including vendor/CRO management is required. Advanced knowledge of GCP, ICH and FDA regulatory requirements. Ability to motivate and develop team with strong management, analytical and problem-solving skills. Must have proficient computer skills with Microsoft Office software (Word, Excel, Project, PowerPoint and Outlook). Competencies SET : Strategy, Execution, Talent (for managers)

ABOUT TE CONNECTIVITY
TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, renewable energy, automated factories, data centers, medical technology and more. With more than 85,000 employees, including 8,000 engineers, working alongside customers in approximately 140 countries. TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat, Instagram and X (formerly Twitter).

 

COMPENSATION
•    Competitive base salary commensurate with experience: $59,000 - 88,500 (subject to change dependent on physical location)
•    Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
•    Total Compensation = Base Salary + Incentive(s) + Benefits

BENEFITS
•    A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.

 

EOE, Including Disability/Vets