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Associate Consultant Clinical Data

Company Name:
Eli Lilly
Company Overview:
Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees in competitive salaries, training and development, and health.
The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.
If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity.
Responsibilities:
The Data Sciences and Solutions department is responsible for global consistency of medical data; structure, content and meaning, acquisition, storage, retrieval, interchange and representation. This requires an in depth understanding of data collection, data flow management, data quality, data technology, dataset delivery, data archiving and data standards.
The Clinical Data role is responsible for providing trial leadership and ownership for a particular trial, set of trials, or programs. The broad applications of this role are:
Provides the single point of requirements definition, strategy communication, and deliverable acceptance to the vendors executing delivery of clinical data management
Provides single point of accountability and deliverable ownership for all aspects of clinical data management.
Acts as the primary contact to the study team and program team members for data science and data solution application.
Acts as a primary contact within the Data Sciences & Solutions organization for all data issues related to assigned trials
Applies specialized therapeutic knowledge and data management discipline knowledge to ensure database deliverables are consistent, accurate, adherent to the data strategy, and deliver the clinical, statistical, and business demands of the team.
Deliverable Ownership and Vendor Management (50%)
Define Lilly business requirements for the study/program for vendors to deliver
Ensure that data management deliverables are delivered to scope, cost, and time objectives
Execute project monitoring and quality oversight of sourcing providers for end-to-end data management activities from study set up through trial execution through dataset delivery
Ensure vendor performance for the program-level flow of data, including across niche vendors and niche data sources
Drives data flow design through consultation, review, and approval of vendor work.
Ensures the data flow design is aligned with the project hypothesis
Approve key deliverables (i.e. Data Quality Delivery Plan, Data lock Plan, Project Plan, database, and observed datasets)
Define and approve data quality and submission deliverables
Trial Leadership (35%)
Ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives
Specifies the data collection tools and technology platforms for the trial/program
Drive standards decisions, implementation and compliance for the study/program
Help create scope scenarios and negotiate outcomes with study teams while taking into account the cost and value of scenarios
Facilitate/assimilate integration of disparate data sources into datasets for decision making
Utilize therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate
Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables
Process Improvement (10%)
Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
Represent Data Sciences processes in cross-functional initiatives.
Actively participate in shared learning across Data Sciences and Solutions
Work with partners to increase vendor/partner efficiencies
Asset Protection (5%)
Understand 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 Data Sciences and Solutions.
Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to CROs or other outside parties
Accept obligation to Lilly for compliance to the integrity of the company
Complete readings of any policy/procedure updates including global medical, Data Sciences and Solutions, and local policies and procedures
Basic Qualifications:
Bachelors Degree (life sciences, computer science, business, engineering)
1-3 years experience in genomics, bioinformatics, PK/biomarker and/or clinical data management in drug development supporting complex data flows in diverse areas such as genetics, pharmacology, and/or clinical research
Demonstrated ability to understand and apply clinical/research data flow, data quality, data interchange, data mining, and data representation principles.
Demonstrated knowledge of the drug development process
Deep therapeutic and molecule knowledge in the specific area of the role
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:
Strong interpersonal and leadership skills Demonstrated problem solving skills
Ability to negotiate and influence at all levels of leadership
Excellent oral and written communication skills
Demonstrated ability to communicate effectively at all levels of the organization
Strong business acumen
Additional Information:
Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status
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