Clinical eDC Study Build Programmer

Role Description

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 test new ideas and/or apply 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.
  • Integrate multi-functional and/or external information and apply 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.
  • 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.
  • Interact with regulators, business partners and outside stakeholders on business issues.
  • Think with end to end in mind consistently managing risk to minimize impact on delivery.
  • Build a diverse multi-functional and internal/external network to understand how different disciplines and approaches contribute to research and development.
  • Focus on defining database solutions and timelines in support of advancing the portfolio.
• Other Responsibilities:
  • Provide coaching and guidance for junior Clinical Study Build Programmers.
  • May or may not lead a team of junior Clinical Study Build Programmers.
  • Participate in the recruitment, development, and retention of a scientific, technical, and operationally capable workforce.
  • Provide effective technical leadership to an agile team of technical staff.
  • Create a team culture that fosters inclusion and innovation and values diversity.
  • Responsible for effective resource planning and supervising clinical study build programmer staff.
  • Ensure all necessary training is provided to staff to support job performance and knowledge.

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.

Requirements

• 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 articulating the flow of data (structure and format) from patient to analysis.
• 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.
• 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.

Benefits

• Full-time equivalent employees will be eligible for a company bonus (depending, in part, on company and individual performance).
• 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.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Company Description

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. 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.