Clinical eDC Study Build Programmer
Eli Lilly and Company, Indianapolis, IN, United States
The Clinical eDC Study Build Programmer is responsible for programming and testing clinical trial data collection databases, including the mapping, testing and normalization of data into a clinical data warehouse. This requires an in-depth understanding of data technology, data flow, data standards, database programming, normalization and testing.
This role will collaborate with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Manager and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.
Responsibilities
Portfolio Delivery
Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components
Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives
Provide insights into study level deliverables (i.e. Data Management Plan, Project Plan, database, and observed datasets)
Support submission, inspection and regulatory response activities
Lead cross Business Unit/Therapeutic Area projects or programs with high complexity
Opportunity to develop and tests new ideas and/or applies innovative solutions that add new value to the portfolio
Project Management
Increase speed, accuracy, and consistency in the development of systems solutions
Enable metrics reporting of study development timelines and pre and postproduction changes to database
Partner to deliver study database per business need and before first patient visit
Follow and influence data standard decisions and strategies for a study and/or program
Apply therapeutic knowledge and possess a deep understanding of the technology used to collect clinical trial data
Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to study build deliverables
Integrates multi-functional and/or external information and applies technical knowledge to data-driven decision making
Enterprise Leadership
Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysis
Represent Data and Analytics processes in multi-functional initiatives
Actively engage in shared learning across the organization
Work to Increase re-usability of forms and edits by improving the initial design
Work to reduce postproduction changes change control process
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
Builds a diverse multi-functional and internal/external network to understand how different disciplines and approaches contribute to research and development
Focuses on defining database solutions and timelines in support of advancing the portfolio
Other responsibilities
The experienced Clinical Study Build Programmer – eDC is expected to provide coaching and guidance for junior Clinical Study Build Programmers.
The Clinical Study Build Programmer – eDC may or may not lead a team of junior Clinical Study Build Programmers. If in supervisory positions, the Clinical Study Build Programmer – eDC is expected to:
Participate in the recruitment, development, and retention of a scientific, technical, and operationally capable workforce that is skilled and knowledgeable in end-to-end global clinical eDC system builds
Provide effective technical leadership to an agile team of technical staff that continuously meets the needs of a changing portfolio and demonstrates judgment-based decision making, and provide leadership in clinical eDC system build delivery
Creating a team culture that fosters inclusion and innovation and values diversity
Responsible for effective resource planning
Responsible for supervising clinical study build programmer 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.
Basic Qualifications
Master’s degree in a scientific or technical field such as Informatics/Analytics, Life Sciences, Information Technology, Computer Sciences (or bachelor’s degree plus 5 or more years of experience in clinical data management, database programming or system validation experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors)
At least 3 years of eDC Study Build Programming 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
Additional Preferences
Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
Knowledge of industry standard clinical technologies including CTMS, EDC (Veeva CDMS preferred, Rave, InForm), eCOA, IxRS, Clinical Data Repositories, etc.
Knowledge of CDISC and CDASH standards/standard terminology
The ability to work independently as well as in a team environment.
Project and Vendor management experience
Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
Demonstrated ability to stay abreast of trends and new information in the profession.
Quick learner to new trends in technology
Excellent leadership, communication (written and oral) and interpersonal skills
Demonstrated teamwork and collaboration in a professional setting
Experience with the following
Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions
Deciding the technology platform (system/database) for data acquisition and aggregation
Utilization of clinical/drug development knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical)
Strong therapeutic/scientific knowledge in the field of research
Society of Clinical Data Management certification
Project management experience
Familiarity with clinical data tools and technologies
Understanding and experience in using data standards
Ability to balance multiple activities, prioritize and manage ambiguity
Demonstrated exemplary teamwork/interpersonal skills
Proven problem solving, attention to detail and result oriented behaviors in a fast-paced environment.
Other Information
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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $79,500 - $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). 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.
#WeAreLilly
#J-18808-Ljbffr
This role will collaborate with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Manager and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.
Responsibilities
Portfolio Delivery
Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components
Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives
Provide insights into study level deliverables (i.e. Data Management Plan, Project Plan, database, and observed datasets)
Support submission, inspection and regulatory response activities
Lead cross Business Unit/Therapeutic Area projects or programs with high complexity
Opportunity to develop and tests new ideas and/or applies innovative solutions that add new value to the portfolio
Project Management
Increase speed, accuracy, and consistency in the development of systems solutions
Enable metrics reporting of study development timelines and pre and postproduction changes to database
Partner to deliver study database per business need and before first patient visit
Follow and influence data standard decisions and strategies for a study and/or program
Apply therapeutic knowledge and possess a deep understanding of the technology used to collect clinical trial data
Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to study build deliverables
Integrates multi-functional and/or external information and applies technical knowledge to data-driven decision making
Enterprise Leadership
Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysis
Represent Data and Analytics processes in multi-functional initiatives
Actively engage in shared learning across the organization
Work to Increase re-usability of forms and edits by improving the initial design
Work to reduce postproduction changes change control process
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
Builds a diverse multi-functional and internal/external network to understand how different disciplines and approaches contribute to research and development
Focuses on defining database solutions and timelines in support of advancing the portfolio
Other responsibilities
The experienced Clinical Study Build Programmer – eDC is expected to provide coaching and guidance for junior Clinical Study Build Programmers.
The Clinical Study Build Programmer – eDC may or may not lead a team of junior Clinical Study Build Programmers. If in supervisory positions, the Clinical Study Build Programmer – eDC is expected to:
Participate in the recruitment, development, and retention of a scientific, technical, and operationally capable workforce that is skilled and knowledgeable in end-to-end global clinical eDC system builds
Provide effective technical leadership to an agile team of technical staff that continuously meets the needs of a changing portfolio and demonstrates judgment-based decision making, and provide leadership in clinical eDC system build delivery
Creating a team culture that fosters inclusion and innovation and values diversity
Responsible for effective resource planning
Responsible for supervising clinical study build programmer 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.
Basic Qualifications
Master’s degree in a scientific or technical field such as Informatics/Analytics, Life Sciences, Information Technology, Computer Sciences (or bachelor’s degree plus 5 or more years of experience in clinical data management, database programming or system validation experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors)
At least 3 years of eDC Study Build Programming 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
Additional Preferences
Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
Knowledge of industry standard clinical technologies including CTMS, EDC (Veeva CDMS preferred, Rave, InForm), eCOA, IxRS, Clinical Data Repositories, etc.
Knowledge of CDISC and CDASH standards/standard terminology
The ability to work independently as well as in a team environment.
Project and Vendor management experience
Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
Demonstrated ability to stay abreast of trends and new information in the profession.
Quick learner to new trends in technology
Excellent leadership, communication (written and oral) and interpersonal skills
Demonstrated teamwork and collaboration in a professional setting
Experience with the following
Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions
Deciding the technology platform (system/database) for data acquisition and aggregation
Utilization of clinical/drug development knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical)
Strong therapeutic/scientific knowledge in the field of research
Society of Clinical Data Management certification
Project management experience
Familiarity with clinical data tools and technologies
Understanding and experience in using data standards
Ability to balance multiple activities, prioritize and manage ambiguity
Demonstrated exemplary teamwork/interpersonal skills
Proven problem solving, attention to detail and result oriented behaviors in a fast-paced environment.
Other Information
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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $79,500 - $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). 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.
#WeAreLilly
#J-18808-Ljbffr