Manager-Senior Manager, Clinical Data Management
Compensation: $95,630.00 - $149,340.00 /year *
Employment Type: Full-Time
Industry: Scientific Research
Manage or participate in clinical data management related activities across multiple studies or at a program level according to Good Clinical Practice (GCP) and Theravance Biopharma Standard Operating Procedures.
- Perform and provide oversight of data management study activities and timelines during study start up, study conduct, database lock, and documentation archival
Represent Data Management for assigned studies within multidisciplinary project teams.
Conduct oversight of Data Management CROs by ensuring data management documents and tasks are completed and delivered in accordance with timelines and data quality standards
Drive development of study related Data Management deliverables (eg, eCRFs, DTAs, etc.)
Participate in the implementation of clinical systems (e.g., EDC, RTSM, eCOA)
Monitor supplier performance to ensure timelines and data quality standards are met
Ensure the use of the Standard CRF Library and CDISC standards, where applicable
Cross-functional process improvement projects
Manage the progress of data management related activities on clinical studies and ensure adherence to appropriate plans and processes, internal operating procedures, intended timelines and budget.
Lead or participate in data management CRO and technology evaluations, qualifications, selections and implementations
Conduct budget negotiations and complete work orders for data management services, review and approve invoices
Education and Experience:
This position requires experience participating in Data Management related activities within a cross-functional team. Demonstrated ability to communicate clearly and work independently with a high level of attention to detail is critical. Experience working with and/or overseeing external suppliers is required. At least 6 years of direct experience in a Data Management related function and 2 years of managerial/leadership experience is preferred.
Doctorate degree & 2 years of directly related experience
Master s degree and 6 years of directly related experience
Bachelor s degree and 8 years of directly related experience
- Experience leading data management related projects with cross-functional stakeholders; strong knowledge of CDM processes and key documents (e.g., CRFs, DMP, etc.)
Experience with EDC and other system used in clinical studies (e.g., RTSM, eCOA)
Managing Suppliers at a Study Level
Knowledge of Good Clinical Practice (GCP), ICH, and Regulatory requirements
Understanding of Inspection Readiness/Regulatory considerations for their role, and the capability to represent the organization during an inspection
Effective and clear communication style, both written and verbal
Problem solver, researches and presents solutions to issues
Contract review and negotiation
- Some travel may be required (<20%)
Associated topics: data analyst, data integrity, data manager, data quality, data warehousing, database, etl, erp, hbase, sql
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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