Clinical data coordinator Jobs in Carmel, IN

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

76,500 - $162,800

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.

Purpose :

The Clinical Data Strategist is a cross functional Data and Analytics scientific leader and key partner with other Data and Analytics Leaders and cross functional staff. Clinical Data Strategist is accountable for setting end to end clinical data strategy, driving cross functional alignment, and realizing improvements in drug development data solutions, technologies, systems, data processes, data products and / or services for a Business Unit and Therapeutic Area. The scope of the Clinical Data Strategist role includes elements of clinical research from early clinical development to post launch clinical research and regulatory submission / inspection activities.

Primary Responsibilities :

Portfolio Delivery

Partner with internal and external teams to provide proactive strategic, scientific and technical input for clinical data planning and execution that enable efficient delivery of data

Accountable for driving project decisions related to clinical data execution options, including integrated functional sourcing, innovation, technology, automation, AI / ML solutions, analytics and data collection modality

Ensure strong linkages exist between clinical design, execution, analytics, delivery and submission

Ensure data from different sources are consistent and easily consumable

Map collected data into predictable source / raw data

Optimization of study build and study build automation tools

Electronic and / or data capture (eDC, eCOA)

DDC (Direct Data Capture) / eSource

Integration of new data capture processes and EHR / EMR-EDC integration

DHT (Digital Health Technology)

Data transfer enhancements

Image tracking and reconciliation

Dashboards (CTMS, Site Enrollment Readiness, Insights)

Early detection of potential issues with Clinical Trial Data

Collaborate with Clinical Data Associate and other Data and Analytics staff on data collection design and optimization

Ensure critical data and processes are implemented and optimized

Understand inconsistencies in data and provide feedback to standards team

Support submission, inspection and regulatory response activities

Enterprise Leadership

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.

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 shared learning and end to end process expertise, demonstrating continuous improvement on key metrics.

Proactively define and drive data strategies to accelerate data execution, delivery, integration, and submission.

Bring greater value to the portfolio by anticipating issues and identifying opportunities for which data solutions can be applied regardless of source.

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 data delivery.

People Management and Development

Contribute to an agile organization that continuously meets the needs of a changing portfolio

Coach up staff who demonstrate expertise in drug development, therapeutic area science, project management and all aspects of clinical data sciences and solutions

Demonstrate and encourage judgment-based scientific decision making, and provide leadership in clinical data strategy, standardization, integration, analytics, automation and data submission

Provide scientific and technical leadership, coaching, and example to the community of Data & Analytics professionals

Foster inclusion, innovation and promote diversity

Basic Qualification :

Master’s degree with 5 years of experience in data management, eDC systems, data technologies (or Bachelor’s degree with 7 or more years of experience)

Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Other Information / Additional Preferences :

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

Experience in clinical drug development with expertise in clinical data management, leading asset level clinical data strategies, defining clinical data flows, determining data modalities and / or defining requirements for data integration, mapping and normalization.

Demonstrated ability to effectively partner / influence to deliver results

Demonstrated ability to understand and apply clinical data management skills, including data flow, data structures, data quality & integrity, data interchange, data mining, and data representation principle

Demonstrated knowledge of clinical concepts and expertise at the indication and compound level in Oncology (early and late phase)

Ability to translate protocol language into data needs

Solid understanding of CDISC and evolving industry practices

ICH(R3) process knowledge / applications

Industry benchmarking

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

Proven ability to develop diverse organizational talent with next level potential

Passionate about improving technological solutions using new technologies such as AI / ML solutions

Lilly currently anticipates that the base salary for this position could range from between $96,000 to $162,800 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. 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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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.

• To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

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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