Clinical Data Lead

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

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 position is responsible for coaching and developing and requires an in depth understanding of clinical data management, that includes data collection, data flow, data quality & integrity.

Responsibilities:

Portfolio Delivery

• 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

• 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 improvement in the Data and Analytics organization

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

Enterprise Leadership

• 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, internal procedures and in compliance with all laws and regulations

• Drive shared learning and end to end process expertise

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

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

• Integrates multi-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

Technical Leadership and Development

• Responsible for recruitment, development, and retention of a scientific, technical and operationally capable workforce skilled and knowledgeable in clinical data management.

• Project effective technical leadership to an agile team of technical staff that continuously meets the needs of a changing portfolio

• Demonstrated judgment-based decision making, and provide leadership in clinical data management delivery

• Create a team culture that fosters inclusion, innovation, promotes diversity

Basic Requirements:

• Master’s degree with 3-5 years of experience (or bachelor's degree with 7 or more years of experience) in clinical drug development or related field with deep technical expertise in clinical data management and execution of data strategies at the compound and study level.

Additional Skills/Preferences:

• Advanced degree (e.g. MSc, PhD) in a scientific or health care field

• Proven ability to lead development of creative data solutions to address clinical development challenges

• Previous supervisory experience

• Proven ability to develop diverse organizational talent with next level potential

• Passionate about improving technological solutions using new technologies

• Society of Clinical Data Management certification

• Domestic and international travel may be required

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 is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly