Associate, Senior Associate, Manager - Clinical Services and Supplies, Ancillaries (CCSI)

Senior Manager, Clinical Central Services and Innovation (CCSI)

The Clinical Central Services and Innovation (CCSI) organization orchestrates solutions that strategically enhance clinical research awareness and accessibility while increasing diversity, reducing burden, and speeding trial execution. This group partners across functions within Clinical Design, Delivery and Analytics (CDDA) to influence trial design and deliver innovation solutions to support the execution of clinical trials globally for all business units across all phases of development.

The Senior Manager, Clinical Central Services and Innovation (CCSI) will collaborate and oversee the team focused on the design and delivery of clinical capabilities including but not limited to clinical trial resourcing solutions, community screening and mobile research event services, clinical emerging technology, digital solution enablement and logistics, alternate locations supporting clinical trial activities, ancillaries, kitting and vendor management.

Purpose

The Clinical Services, Supplies & Capabilities (CSSC) organisation is responsible for strategically planning and supplying materials, trial support services and innovative capabilities to support the execution of clinical trials globally for all business units across all phases of development. This group is within the Clinical Capabilities organization and partners across functions within the CDDA and PRD to influence trial design and provide solutions to operationalise these trials and enable asset strategies across the portfolio.

The purpose of the Ancillaries Team is to identify portfolio demand for ancillary supplies, translate the demand to a sourcing strategy and operational plan, and manage the operational plan to completion. Available sourcing strategies include utilisation of external partner/vendor networks as well as internal capabilities.

The Associate, Senior Associate, Manager is responsible for translation of ancillary demand into trial level operational plans and management of those activities to completion for small to medium-scale global clinical trials. The Associate, Senior Associate, Manager is also responsible for vendor management for assigned trials and participation in improvement projects and strategic initiatives to improve Ancillary Supply Capabilities. In addition, this role may support other types of clinical supplies using defined processes.

Primary Responsibilities

Daily Operations in support of small to medium-scale global clinical trials:

• Collaborate with cross-functional partners to understand the Ancillary Supply needs.
• Translate Ancillary Supply demand to a global sourcing strategy.
• Design operational plans based on clinical requirements, ancillary supply sourcing strategy, and partnership with clinical study team.
• Responsible for the completion of all documentation that defines the operational plan such as but not limited to supply templates, work orders, and item listings and tools that define trial budgets and timelines.
• Responsible for the delivery and closeout of Ancillary Supply operational plans on time, on budget, and within scope.
• Manage supply dispensation plan to support global delivery of Ancillary Supplies.
• Proactively manage distribution to sites to ensure on time delivery and resolve issues with sites and partners/vendors as they arise.
• Collaborate with PR&D Quality to ensure compliance by creating and routing change controls, dispositions, problem reports, undeliverable, Quality Notifications, Notifications to Management as well as documentation for support of pro-cesses outside of the established Ancillary scope.
• Maintain expertise in the use of electronic data management and enterprise systems such as Quality Docs, SAP, SharePoint, and Teams Sites.
• Maintain local tools in support of consistent delivery of Ancillary Supplies.

Partner and Vendor Management

• Manage external partner and vendor relationships.

Capability Development and Innovation

• Implement plans to develop and improve Ancillary Supplies strategies, technologies, and processes.
• Identify, monitor, and communicate global customer (internal and external) needs/requirements related to the delivery of Ancillary Supplies.

Minimum Qualification Requirements

• Bachelor's degree in pharmacy, engineering or scientific related field or equivalent work experience.
• 2+ years of experience in at least one of the following: clinical research, distribution, supply chain, logistics, clinical trial materials, project management, or direct quality support for any of these areas.

Other Information/Additional Preferences

• Knowledge of the pharmaceutical industry, drug development process, and supply chain practices.
• Knowledge and/or experience in project management.
• Proficient in computer technology used in office and scientific areas, such as Word, Excel, SAP, and molecule databases.
• Proficient in managing SharePoint lists, libraries, and Microsoft teams.
• Experience working with third parties.
• Strong attention to detail.
• Ability to work independently and effectively manage competing priorities.
• Ability to adapt to a changing environment.
• Good interpersonal and leadership skills.
• Excellent oral and written communication skills.
• Demonstrated strength in logical thought, problem solving ability, and critical thinking.
• Ability to communicate and influence across functional boundaries.
• Knowledge of regulatory and/or quality requirements governing clinical development.
• Knowledge of GxP regulations and requirements (GMPs, GDPs and/or GCPs).
• Experience in deviation and/or change management.
• Language Requirements: Must speak fluent English.
• 10% or less travel.

Accommodations and Disability

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 for further assistance.

Equal Opportunity Statement

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.