Clinical eDC Study Build Programmer

Eli Lilly and Company • Indianapolis, IN

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About The Position

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.

Requirements

• 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.
• 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.
• 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
• 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.

Nice To Haves

• Project and Vendor management experience
• Society of Clinical Data Management certification
• Project management experience
• Familiarity with clinical data tools and technologies

Responsibilities

• 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
• 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
• 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
• Provide coaching and guidance for junior Clinical Study Build Programmers.
• 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.
• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees