Lilly (Sr.) Clinical Data Officer in 上海, China
Type of Employment:
Purpose:Data Sciences & Solutions are 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 Snr. Officer/Officer - China Clinical l Data is responsible for providing leadership and ownership for a particular trial, set of Trials, molecules, or programs. The broad applications of this role are:
• Data domain leadership: focused on understanding and guiding the organization on utilization of a particular domain of data, e.g., data aspects of regulatory submission/ response, pharmacokinetics data, health outcomes data, patient claims databases, etc.
• Provides the single point of requirements definition (collection, validation and delivery), 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 and molecules.
• 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, regulatory, and business demands of the team.
- Data Strategy (25%)
• Develop, communicate, and drive implementation of China data strategy aligned with the glob al clinical plans for a data asset (molecule, therapeutic area, data domain, etc.) throughout its lifecycle, including early development, globalization and commercialization, scientific data disclosure plans, brand council, external dataset, etc.
• Focus on understanding and guiding organization to support China regulatory domains. Activities include lobbying efforts internally across functions and externally with regulatory authorities, confirming all regulatory data submission needs from DSS are met, and accelerating the submission timing in key markets
• Develop and ensure that deep knowledge of internal, external and regulatory requirements/ expectations in China relevant to the data domain are understood, well communicated, and applied to data deliverables and global data strategy, and influence external organizations to further Lilly interests in the industry.
- Data Solutions (10%)
• Proactively drive the use of data processes and tools to accelerate the development of a data asset. Bring greater value to the portfolio by anticipating issues and identifying opportunities for which data solutions can be applied.
- Deliverable Ownership and Vendor Management (30%)
• 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, data base, and observed datasets)
• Define and approve data quality and submission deliverables
- Trial and Molecule Leadership (20%)
• Ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives
• Specifies the data collection tools and technology plat forms for the trial/program and molecule
Drive standards decisions, implementation and compliance for the study/program and molecule
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 (MHLW, JPMA, FDA, SFDA, 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 d the confidential nature of company in formation and takes necessary steps to ensure its protection. This includes understanding various aspects of Privacy as i t 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
Minimum Qualification Requirements:
Bachelor's degree or equivalent experience
Minimum of 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.), demonstrating the 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
Mandarin written and verbal communication capability
Clinical knowledge and an ability to liaise effectively w it h study team members (i.e. Data Sciences, Statistics, PK. Operations, Medical)
Strong therapeutic/ scientific knowledge Project management experience
Vendor management experience
Virtual team environment experience
Other Information/ Additional Preferences:
Strong interpersonal and leadership skills
Excellent oral and written communication skills
Familiarity with clinical data tools and technologies
Technical know ledge 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
Req Id: 53940BR