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.
• 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 Company 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, Datalock 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 Company 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
• Bachelor’s degree in drug development in areas intersecting with clinical data management (e.g., clinical operations, statistics, information technology, health outcomes, etc.)
• 3 years experience in clinical data management and/or 5 years experience in drug development 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.
• Client does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
• Demonstrated ability to:
• Articulate the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions
• Decide the technology platform (system/database) for data acquisition and aggregation
• Clinical knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical)
• Strong therapeutic/scientific knowledge
• SCDM certification
• Project management experience
• Vendor management experience
• Virtual team environment experience
• 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
• Domestic and International travel may be required
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