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. 

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:

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 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

• 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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: 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) and 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

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).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.

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