Associate Director - Clinical Data Lead

Associate Director - Clinical Data Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Purpose:

The Clinical Data Lead is a Data and Analytics technical leader and key partner with other Data and Analytics Leaders and Directors. The Clinical Data Lead is accountable for technical leadership in the execution of global clinical data management work, driving prioritization and alignment of study deliverables and realizing improvements in clinical data management activities and processes. The scope of the Clinical Data Lead role includes elements of clinical research from early clinical development to post launch clinical research activities.

The Clinical Data Lead is responsible for coaching and developing staff to enhance scientific, technical, and operational depth. This role requires an in depth understanding of global clinical data management, including data collection, data flow management, data quality & integrity, data technology, data archiving, data standards and data submission.

Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Portfolio Delivery

Technical contributor that leads in the delivery of clinical data execution

Accountable for the completeness, accuracy, and consistency of data to meet the standards of quality expected for reporting to regulatory bodies

Partner with other clinical leaders to provide proactive strategic, scientific and technical input on clinical data planning and execution that enable efficient delivery of these data

Contribute to project decisions related to global clinical data execution options

Ensure strong linkages exist between study build, execution, analytics and archival

Operationally responsible for the clinical data management activities related to the effective planning for study startup and execution

Partner closely with Data and Analytics leadership and other functions to effectively plan, forecast, and manage the end-to-end global clinical data management, validation, study build, and filing/archiving resources required to deliver all sanctioned projects

Drive efficiency and continuous improvement in the Data and Analytics organization

Identify key functional capability gaps early enough to help ensure robust processes in place to meet team needs and/or manage expectations to avoid downstream delivery delays

Lead large-scale cross Business Unit/Therapeutic Area projects or programs with high complexity

Enterprise Leadership

Within functional and cross-functional teams, exhibit strong business acumen, strong problem-solving skills and agility to adjust to changing business priorities and needs

Represent the Data and Analytics organization at appropriate internal and external venues

Maintain awareness of regulatory requirements, particularly those related to the US, EU, Japan, and China

Accountable for fiscal responsibility of execution of clinical data plans

Ensure that activities are performed according to established guidelines, best practices, and in compliance with all laws and regulations

Drive continuous improvement of key performance metrics

Drive shared learning and end to end process expertise

Proactively drive the use of data processes and tools to accelerate clinical data management activities and deliverables

Bring greater value to the portfolio by anticipating issues, identifying opportunities and leading technical solutions

Articulate the value of data solutions in terms of reliability, time, cost, quality and scalability

Integrates cross-functional and/or external information and applies technical knowledge to data-driven decision making

Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization

Interacts with regulators, business partners and outside stakeholders on business issues

Thinks with end to end in mind consistently managing risk to minimize impact on delivery

Act as a point of contact for study management teams and for clinical development regarding data management issues

Ensure timely and appropriate escalation of complex issues to senior…