Eli Lilly and Company

Associate-Data Solutions

Location
Indianapolis, IN
Posted
Nov 17, 2018
Ref
45621
Required Education
Associate Degree
Position Type
Full time
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 39,000 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.

Responsibilities
Clinical development requires global consistency of medical data; structure, content and meaning, aquistion, storage, retrieval, interchange, and representation. This requires personnel with an in-depth, expert understanding of data collection, data flow management, data quality, data technology, data archiving, data standards, and data submissions activities.

As a Data Solutions Associate, you are responsible for the overall management and delivery of data; which includes providing data solution expertise for clinical pharmacology at the molecule or multi-molecule level. Broadly, this role provides leadership, direction and consultation for data requirements definition and strategy to enable effective delivery execution of data packages to the broader clinical pharmacology organization. You will act as the primary contact to the study team and program team members for clinical pharmacology solutions. Your specialized domain knowledge will ensure database deliverables are consistent, accurate, adherent to the data strategy, and deliver the clinical, statistical, and business demands of the team. You will also be responsible for identifying, leading and supporting strategic initiatives within Clinical Pharmacology to enhance operational efficiencies. Other aspects of this role include:

Technical Leadership
  • Consults to ensure that data acquisition, database design, and observed data set requirements are reflective of specific protocol objectives.
  • Provides direction and expertise to study teams to secure adherence to Lilly standards and facilitates recognition of the need for new/changed standards as needed.
  • Provides input to ensure that controls are in place to secure data integrity and patient privacy.
  • Proactively anticipates and prevents technical problems from impacting final data deliverables, mentors and shares lessons learned with others on technical problem prevention and resolution.
  • Supports project teams on achieving client satisfaction via ownership of the delivery of quality data, on-time, and within budget.
  • Proactively provides technical guidance to study teams regarding data system processes and requirements.
  • Provides expert review and guidance in the development of CRF/eCRF design specifications, validation specifications and report design.
  • Ensures consistency of data across studies and programs, applying both Lilly standards and industry initiatives (e.g. CDISC) as necessary.
  • Utilizes therapeutic knowledge and possess a deep understanding of technology and processes used to review data to ensure database deliverables are consistent and accurate.
  • Effectively applies knowledge of internal, external, and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables.
Vendor Oversight & Relationship
  • Establish, define, and execute quality assurance oversight plans and metrics associated with outsourced services
  • Ensure vendor performance for the program level i.e., flow of data, including across niche vendors and niche data sources
  • Manage through effectively 1) leveraging the data planning framework; 2) utilizing good project management discipline; 3) providing timely and clear communications; and 4) exercising proactive mitigation.
  • Works with internal partners to increase vendor/sponsor efficiencies and support collaborative relationship

Process Execution & Improvement
  • Actively lead, drive and influence the cross-functional team on data delivery strategies, timelines, and deliverables
  • Continually seeks and implements means of improving processes to reduce cycle times & speed delivery of data for decisions
  • Identify and lead shared learning across with the broader group on foundational experiences.
  • Work with partners to increase vendor/partner efficiencies.
  • Collaborates with peers to establish global data management competency models and assist with the development of training programs and ensure staff achievement of role competencies
  • Contributes to the development of others by being an active source of constructive coaching and feedback to co-workers
Submission Support
  • Coordinate delivery of submission packages relative to data management deliverables (i.e. aCRFs, DDD, datasets, notable CRFs) for clinical pharmacology including timeline management and location/conversion of legacy trial data.
  • Maintain suite of tools for document creation/review of submission deliverables
  • Provide ongoing solutions for publishing requirements
  • Maintain current knowledge of industry and regulatory standard requirements for submission activities, frequently liaisons with key cross functional partners
  • Partner with team members for regulatory responses
  • Facilitate the availability of data for submission activities
Asset Protection
  • Understands the confidential nature of company information and takes necessary steps to ensure its protection. This includes understanding various aspects of Privacy as it relates to the data managed within function.
  • Ensures that an appropriate confidentiality agreement has been executed before disclosing confidential company information to CROs or other outside parties
  • Accepts obligation to Lilly for compliance to the integrity of the company
45621BR

Basic Qualifications
  • Bachelor's degree.
  • Minimum of 2+ years experience in clinical data management or in areas intersecting with clinical data management (e.g., clinical operations, statistics, information technology, health outcomes, etc.),
  • 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 Skills/Preferences
  • Ability to work in ambiguous situations within the team to identify and resolve complex problems
  • Demonstrated extensive in-depth knowledge of data management processes and principles in the specialty and the ability to articulate: Data flow, structure and format of data, CRF Design, Clinical Data Base Development, Randomization, Data Acquisition, Data Movement, EDC, CRFProcessing, Submission Assembly and Validation Procedures
  • Clinical knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical)
  • Demonstrated ability to understand customer perspective and deliver solutions that meet expectations
  • Ability to work cooperatively with key internal and external stakeholders to ensure success
  • Strong SDTM and therapeutic/scientific knowledge
  • Vendor mgmt, Project mgmt, and virtual team environment experience
  • SCDM certification
  • Strong interpersonal and leadership skills
  • Excellent oral and written communication skills
  • Familiarity with clinical data tools and technologies
  • Technical knowledge to develop requirements and/or study/project deliverables (i.e. SAS,Oracle)
  • Experience in forms design and layout
  • Understanding and experience in using data standards
  • Knowledge of medical terminology
  • Process management expertise
  • Travel (domestic) possible (0 to 5%)


Additional Information
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.