Associate Director - Clinical Data Lead

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 116,000 - 169,000; Full time

Benefits offered by this job

401(k) plan

Vacation benefits

Medical coverage

Dental coverage

Flexible benefits

Life insurance

Well-being programs

Job summary

Lilly in Indianapolis, IN is seeking an Associate Director - Clinical Data Lead to drive global clinical data management strategy and execution across development programs. You will coach staff, lead cross-functional teams, ensure data quality and regulatory readiness, and partner with Data and Analytics leaders to optimize study planning and filing activities.

The role requires deep expertise in data standards, data flow, and compliance with US/EU/Japan/China regulations, and offers a path to

Qualifications

• Bachelor’s degree plus 7+ years clinical data management experience.
• Authorized to work in the United States.
• Master’s degree and/or SCDM certification preferred.

Responsibilities

• Lead delivery of global clinical data execution and ensure data quality for regulatory reporting.
• Provide proactive strategic input on clinical data planning and execution to enable efficient delivery.
• Mentor and develop staff to enhance scientific, technical and operational depth.
• Oversee study startup and execution planning for clinical data management activities.
• Collaborate with Data and Analytics leadership to plan end-to-end validation, filing and archiving resources.

Skills

Clinical data management

Leadership

Regulatory knowledge

Data standards

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

Tools

SAS

SQL

ETL tools

CDISC standards

Job description

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.

Job Description Associate Director - Clinical Data Lead 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

• 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
• Interact 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 management
• Lead or otherwise participate in the development review and implementation of continuous improvements processes policies SOPs and other guidance / process documents that govern CDR (clinical data representative) responsibilities
• May serve as lead for multiple products or indications of considerable complexity within a therapeutic area including leading cross functional working groups
• Support health authority inspections and audits as relates to clinical data management activities
• Technical Leadership and Development Participate in the recruitment develop and retention of a scientific technical and operationally capable workforce skilled and knowledgeable in end‑to‑end global clinical data management.
• Provide effective technical leadership to an agile team of technical staff that continuously meets the needs of a changing portfolio
• Create a team culture that fosters inclusion and innovation and values diversity
• Responsible for effective resource planning
• Responsible for supervising clinical data management staff as assigned including aspects of training mentoring goal setting performance management and engagement.
• Other activities include setting objectives soliciting feedback from stakeholders and conducting performance reviews to foster growth of staff.
• Ensure all necessary training is provided to staff to support job performance and knowledge.
• Help to remove any barriers or obstacles that impede them from achieving company functional and individual objectives

Minimum Qualifications

• Bachelor's degree 7 + 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.
• Qualified applicants must be authorized to work in the United States on a full‑time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role including but not limited to F‑1 CPT F‑1 OPT F‑1 STEM OPT J‑1 H‑1B TN O‑1 E‑3 H‑1B1 or L‑1.
• Additional Preferences: Master’s degree with 3‑5 years of experience in clinical drug development or a related field with deep technical expertise in clinical data management and execution of data strategies at the compound and study level.
• Advanced degree (e.g. MSc PhD) in a scientific or health care field.
• 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 proud to be an EEO Employer and does not discriminate on the basis of age race color religion gender identity sex gender expression sexual orientation genetic information ancestry national origin protected veteran status disability or any other legally protected status.

Employee Resource Groups (ERGs)

• Africa
• Middle East Central Asia (AMECA)
• Black Employees at Lilly (BE@Lilly)
• Chinese Culture Network (CCN)
• EnAble
• Evolve
• Lilly Indian Network (LIN)
• Organization of Latinx at Lilly (OLA)
• Pride (LGBTQ+ Allies)
• Veterans Leadership Network (VLN)
• Women’s Initiative for Leading at Lilly (WILL)

Actual compensation will depend on a candidate’s education experience skills and geographic location. The anticipated wage for this position is $115,500 – $169,400. Full‑time equivalent employees also will be eligible for a company bonus (depending in part on company and individual performance).

In addition Lilly offers a comprehensive benefit program to eligible employees including eligibility to participate in a company‑sponsored 401(k) pension vacation benefits eligibility for medical dental vision and prescription drug benefits flexible benefits (e.g. healthcare and/or dependent day care flexible spending accounts) life insurance and death benefits certain time off and leave of absence benefits and well‑being benefits (e.g. employee assistance program fitness benefits and employee clubs and activities).

• company‑sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical dental vision and prescription drug benefits
• flexible benefits (e.g. healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well‑being benefits (e.g. employee assistance program fitness benefits and employee clubs and activities)

Lilly reserves the right to amend modify or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

We continue to look for ways to include innovate accelerate and deliver while maintaining integrity excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

#WeAreLilly