Senior Manager, Manager Clinical Data Management
|Contact Name:||Director of The RFT Group|
Our client is a fast growing highly profitable multinational biotechnology company with an exciting pipeline of drug compounds at an advanced stage in research. With a highly experienced and successful executive management team this company has a newly created vacancy for an experienced Senior Manager, Manager, Clinical Data Management. This newly created management position will be located in Dublin.
Manage or participate in clinical data management related activities across multiple studies or at a program level according to Good Clinical Practice (GCP) and company 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
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 OR
Master’s degree and 6 years of directly related experience OR
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%)
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