Lilly Assoc Consultant-Clinical Data in Indianapolis, Indiana
Do you have an in depth understanding of data collection, data flow management, data quality, data technology, dataset delivery, archiving and data standards? Does a role that incorporates trial level clinical data strategy including database structure, content and meaning, acquisition, storage, retrieval, interchange, delivery and representation peak your interest? If so, we have the role for you.
As a Clinical Data Associate you are responsible for providing trial leadership and ownership for a particular trial, set of trials, or programs. You will work closely with our Clinical Design Hub and key study partners to define, implement, and deliver clinical data management packages.
To ensure successful portfolio strategy/planning/delivery, you will define the Lilly business requirements for the study/program vendors ensuring vendor performance for the program-level flow of data. You will validate and drive the data flow design is aligned with the project hypothesis through consultation, review, and approval of the vendor work. Additionally, you will:
Confirm data management goals 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
Approve key deliverables (i.e. Data Quality Delivery Plan, Datalock Plan, Project Plan, database, and observed datasets)
Define and approve data quality and submission deliverables.
You role in effective project management is highly important to this role. You will use your project management skills to ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives. Driving standards decisions, implementation and compliance for the study/program while specifying the data collection tools and technology platforms for the trial/program are key in this role. You will facilitate/assimilate integration of disparate data sources into datasets to assist in way we make decisions. You will also:
Help craft scope scenarios and negotiate outcomes with study teams while taking into account the cost and value of scenarios
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 to data deliverables.
Continuously improve processes is very important in the clinical data space. To do this, you will seek and implement means to reduce cycle time and decrease work effort.
You will represent data sciences’ processes in cross-functional initiatives by actively participating in shared learning across Clinical Labs and Data Sciences organization. It will also be important to work with our vendor/partners to increase efficiencies as needed.
It is essential that you 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 handled within the organization. Additionally, you will:
Ensure that an appropriate confidentiality agreement is 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
3 years Data Management experience or 5 years experience in drug development in areas intersecting with clinical data management (e.g., clinical operations, statistics, information technology, health outcomes, etc.)
Masters degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy, Business
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
Vendor management experience
Familiarity with clinical data tools and technologies
Technical knowledge to develop requirements and/or study/project deliverables (i.e. SAS,Oracle, programming, analytical tools)
Experience in forms design and layout
Understanding and experience in using data standards
Experience with designing and handling of eCOA data
Knowledge of medical terminology
Domestic and International travel may be required
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.
Clinical Data Associate-Oncology
Bachelor’s degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy
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.
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.
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