Associate Director - Clinical Results Systems

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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.

Clinical Trial Foundations as part of Clinical Design, Delivery & Analytics (CDDA) provides leadership in the strategy and development of contemporary clinical trial processes, technologies, information, and capabilities and in shaping external policy and guidance to speed the delivery of medicines to patients globally.

The Associate Director Clinical Results Reporting Systems role requires broad expertise of the systems used in the data collection process area, specifically relating to results reporting systems used by Data & Analytics (DnA).

This requires an in-depth understanding of standards from CRF to TFLs, as well as the supporting processes and technology.

Working closely across geographies with colleagues in DnA, LRL, CDDA, Tech@Lilly, and other components of the R&D organization, the Associate Director Results Reporting Systems is responsible for managing and supporting multiple complex projects and technologies and ensures the on-time delivery of solutions that are aligned to business processes.

The Associate Director ensures quality practices are in place around systems and maintains a solid understanding of the supporting business processes and application support requirements and provides influence at multiple levels within the business and by partnering with Quality and IT where appropriate.

Responsibilities :

Coordinate and lead the support of existing technology and tools.

Understand business processes and support needs across all departments within DnA.

Partner with Tech@Lilly assist with the implementation of Clinical Trial Foundation (CTF) technology needs.

Develop and maintain a global power user network for the supported applications.

Assist with the development and maintain metrics to evaluate the effectiveness of support delivery.

Partner with vendors and Tech@Lilly to enable appropriate technology for external business partners.

Assist with the management of existing vendor relationships for systems support.

Partner with Tech@Lilly and Computer Systems Quality to develop appropriate validation work for software and tools.

Identify and resolves quality issues related to system, tools, and technology.

Support internal audits and external inspections

Proactively optimize support delivery.

Partner with CTF management, business domain experts, Tech@Lilly, and other functions to implement and support new technology to meet business needs.

Define, lead and implement implementation plans to deliver on technology strategies and improvements

Develop critical success factors for pilots / projects to ensure clear criteria exists to enable decision making

Identify, monitor and communicate global customer (internal and external) needs / requirements related to process and / or technology performance and improvements

Lead organizational change, communication planning and training initiatives

Have an awareness of the modernization efforts within the CTF and DnA organizations.

Appropriately challenge and influence multi-functionally.

Effectively translate technical problems and solutions to a non-technical audience.

Ensure proper business requirements have been defined for all IT related projects by partnering with appropriate departments within CTF and DnA

Ensure systems are meeting defined business requirements through coordinated testing and monitoring efforts.

Assist with the determination of priorities of projects in collaboration with CTF management when competing for limited resources.

Work closely with Tech@Lilly to ensure alignment of end user tools with overall Tech@Lilly strategy.

Minimum Requirements :

Bachelor’s degree

Five or more years of experience in clinical drug development from data collection through analysis / integrated databases / submission work and / or in data driven information systems

Preferences :

In depth knowledge of Statistical Sciences, CDISC Standards, and / or Data Management with respect to clinical trial data collection, analysis and reporting activities

Experience in leading multiple complex projects and / or teams to achieve superior business results.

Demonstrated ability to provide effective account management with internal business partners

Demonstrated leadership; ability to achieve results through others and influence across functions

Strong problem-solving skills : able to recognize problems before they become serious and take corrective action

Excellent self-management and organizational skills are essential; able to manage workload and adjust personal priorities, as needed based on guidance from supervision

Excellent oral and written communication skills; able to communicate clearly and succinctly up and down the organization

Flexibility to adjust quickly and effectively to frequent change and altered priorities

Ability to communicate and influence across functional boundaries

Demonstrated ability to communicate issues and raise potential issues

Effective teamwork skills; able to adapt to diverse interpersonal styles

Sound understanding of integrating and managing big data and coding in statistical based tools like SAS and / or R

Experience validating systems and software under regulatory requirements around ICH, GCP, Pharm, etc.

Experience in leading all aspects of process changes

Demonstrated negotiation skills; applies experience and knowledge to persuade others to reach sound decisions

Project management and Data Management experience preferred

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