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 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.
(Sr.) Manager, CTSS will ensure that CTSS Representatives are effectively supporting the clinical operations team with respect to system maintenance, contract execution, invoice retrieval, IP/non-IP supplies and administrative tasks like preparation of submission dossiers, filing and reporting, and payment activities. (Sr.) Manager, CTSS will ensure all above-mentioned supporting activities in compliance with Good Clinical Practices (GCP) and appropriate Quality Standards.
1. Leadership
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Provides line management support for Country CTSS Representatives, ensure the delivery of the service.
- Ensure coaching and supervision of the CTSS staff.
- Recognize and reward direct reports proactively.
- Monitor work/life balance.
- Ensure training program is in place for direct reports.
- Conflict resolution, issue management and appropriate escalation.
2. Set up and maintain the capabilities and efficiencies of CTSS team to provide sustained administrative supporting level. Develop CTSS function capability and improve productivity with the book of work increasing, ensure the administrative supporting level sustained high.
- Responsible for updating of clinical research related system, e.g, CDE Clinical Trial Registry, eTMF etc.
- Oversight the logistic support for site safety mailing ethical committee submission.
- Provide operational expertise and oversight the operational support in local IIT, include preparing IIT study contract and/ or IP based on internal approved IIT proposal, tracking IIT enrollment progress, coordinating distribution to site and processing site payment, if applicable.
- Oversight the local site study equipment leasing process, investigator/sponsor TMF archival process.
- Ensure the hard copy TMF are managed compliant to GCP.
3. Deliver site and vendor contract and payment in a compliance way that support the accelerated site initiation and during trial execution.
- Ensure vendor and sites contract process well executed in the system, fully in compliance with global and local finance policy.
- Balance the investigator sites and Lilly finance requirement to process clinical trials payment in a timely manner.
- Identify opportunities and take innovative approach that could lead to site payment acceleration.
4. Work with cross function team to proceed Third-Party Organization (TPO) sourcing process that meet Clinical Operation deliveries requirements which related to CTSS service, trial equipment leasing and calibration, printing, translation.
- Develop team capability in vendor management that provide enough support in trial execution where required.
- Oversight vendor performance on a regular basis.
- Partner with study team to provide feedback to vendor and get involved in vendor management for service improvement where necessary.
- Develop new service vendors while business needs evolve.
- Ensure the process and practices are following finance and other relevant policy.
5. Maintain the relationship with stakeholders to meet CTSS team deliveries requirements, including but not limit to global trial capabilities team, Finance, Procurement, IQVIA CRA team, ClinOps CSM team etc.
6. Oversight the CTSS representatives for the logistics and management of Investigational Product (IP)/non-IP supplies in collaboration with local TPO from ordering, receipt, storage, delivery to/return from sites until destruction.
- Sourcing of IP (commercial material) and non-IP supplies as study team request.
- Support import/export/shipment/return/destruction activities related to IP/non-IP supplies.
- Provide operational expertise to IP distribution management training for CRAs.
- Coordinate with IP SME and MQR to ensure appropriate audit/inspection responses are provided and implement corrective actions.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.
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