Clinical Data Associate

About the Role

The Clinical Data Associate is accountable for the end-to-end clinical data sciences delivery for a clinical study, including clinical database build, data acquisition, storage, retrieval, and exchange. This role requires in-depth understanding of the clinical study design, data standards, study protocol, data flow, systems, and processes for collecting and managing clinical study data. The Clinical Data Associate is required to represent the clinical data sciences function and collaborate with and manage key study collaborators in achieving study milestones. The role is responsible for providing clinical data science leadership and ownership for a particular clinical study, set of studies, or programs.

Key Responsibilities

• Clinical Data Science Delivery
• Implement project monitoring and quality oversight of sourcing providers for end-to-end data management activities from study set-up to trial execution through database lock delivery.
• Ensure vendor performance for the program-level flow of data, including across niche vendors and niche data sources (pharmacokinetics, immunogenicity, biomarkers).
• Partner with the Clinical Data Strategist in ensuring data flow design and data collection meet the requirements of the study protocol.
• Develop the Data Management Plan (DMP) and maintain the DMP throughout the lifecycle of the clinical study while ensuring that the DMP is followed in accordance with the study design and study protocol requirements.
• Drive data cleaning activities throughout study execution. Use therapeutic knowledge and possess a deep understanding of the technologies used to review data to ensure database deliverables are consistent and accurate.
• Help identify and drive implementation of post-production changes to the Clinical Database.
• Develop and maintain plans for key study deliverables (i.e., Data Quality Delivery Plan, Datalock Plan, Project Plan).
• Provide consultation and a high level of expertise in data management processes, principles, and deliverables to support clinical studies.
• Represent clinical data sciences in inspections and support inspection readiness efforts within the clinical data sciences function and multi-functionally.
• Effectively apply knowledge of applicable internal, external, and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables.
• Manage and drive requests for copyrights and translations for study-related documents.
• Drive build implementation for eCOA, ensure execution of eCOA deliverables (on time with high quality), and serve as eCOA point of contact (POC).
• Project Management
• Ensure that the clinical data science deliverables meet scope, cost, and time objectives.
• Manage study timelines for clinical data deliverables (FPV to database lock)
• Drive the planning, readiness, coordination and communication of activities leading to database lock
• Coordinate/lead data management milestones for data transfers and database locks.
• Manage scope of the deliverables through scenario planning and negotiating desired outcomes with study teams while taking into account the cost and value of scenarios.
• Practice effective risk management to mitigate or manage risks to study deliverables.
• Communication
• Act as primary communication point for all data management activities related to a clinical study.
• Report out status of data management milestones and data quality.
• Partner with external data vendors: understand specifications to import multiple types of data, work with technical groups to ensure timely loads of external data sets into the sponsor's database.
• Demonstrate excellent written and verbal communication skills, including the ability to represent the Data and Analytics organization and influence team members to drive data-driven decisions.
• Partner with across functional team members to ensure trial success through robust oversight/review.
• Process Improvement
• Continually seek and implement opportunities for process improvements, automation to drive efficiencies, reduction of cycle times, and improvements in quality.
• Represent clinical data sciences’ processes in cross-functional initiatives.
• Actively engage in shared learning across the Data and Analytics organization.
• Work with partners to increase vendor/partner efficiencies.
• Recommend new or improved processes relating to clinical data management.

Requirements & Tech Stack

• Master’s degree in a scientific or technical field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences
• OR Bachelor’s degree plus 3 or more years of experience in clinical data management or areas that closely intersect with clinical data management, such as statistics, data analytics, information technology, health outcomes, etc.
• Demonstrated ability to effectively partner/influence a virtual team and drive a technical project to deliver positive results
• Demonstrated ability to lead development of creative solutions to address data-related clinical development challenges
• Passion for improving technological solutions using new technologies
• Working knowledge of programming languages & industry tools such as Tableau, PowerBI, Python, SAS, R and Shiny for reporting, metrics, and visualizations, along with P-SQL, T-SQL for DBMS.
• Experience with:
• Articulating the flow of data (structure and format) from study start-up to analysis and applying this knowledge to data solutions
• Utilization of clinical/drug development knowledge and an ability to liaise effectively with study team members (i.e., Statistics, PK, Operations, Medical)
• Strong therapeutic/scientific knowledge in the field of research
• Knowledge of medical terminology
• Ability to balance multiple activities, prioritize and manage ambiguity
• Demonstrated exemplary teamwork/interpersonal skills
• Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment

Qualifications

• Society of Clinical Data Management certification
• Willing and able to work onsite in Indianapolis, IN
• Domestic and international travel may be required