Job Title
Principal Clinical Data Manager
Functional Area
Data Management
Education Requirements
Bachelor degree in biological sciences or related disciplines in the natural science/health care.
Technical Skills Requirements
Expertise in EDC/Paper based Data Management Systems like Rave, OC RDC, Inform, etc. Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. Should have knowledge of MS Project Good IT hardware/software knowledge . In-depth knowledge of CDISC standards, especially CDASH and SDTM Proven data manipulation and analytical skills. Strong influencing & general communication skills. Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. Strong ability to be flexible and adapt to change, to work independently, and take a leading and collaborative role in multi-disciplinary teams. Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.Experience requirements
Preferably 7+ years of experience working as a Senior Data Manager for clinical trials. In-depth knowledge of medical terminology, clinical data, and ICH Good Clinical Practices, 21 CFR part 11 and other regulatory requirements .Desirable requirements
Clinical Data Manager certification (CCDM) by Society for Clinical Data Management (SCDM) Preferably have SAS programming skills Desirable experience in one or more of the following therapeutic areas: Chronic diseases, oncology (solid tumour and/or haematology), respiratory, immunology, neuroscience, ophthalmology, infectious diseases, cardiovascular diseaseResponsibilities
Accountable for delivery of multiple studies in a clinical program, including leadership and oversight of other data managers responsible for specific deliverables within the program. Able to manage more complex studies Assist with the development of strategic and organizational procedures and policies and attend management and team meetings as required. May lead a functional area within data management May lead functional process improvement / tool development initiatives Subject Matter Expert in data management processes and multiple clinical data management systems Able to support / coach / train others High motivation to work on teams where high-level collaborative and influencing skills are required Ability to work with minimal supervision and with non-standard, complex processes Responsible for maintaining Data Management component of Trial Master File. Responsible for managing external data vendors Responsible for performing the Data Management activities for clinical studies in accordance with the customer’s expectations, DMP, Protocol, CRFs, relevant SOPs and ICH GCP. Effectively maintains oversight of all Data Management activities and deliverables for a study through to successful completion To be a high-level contact for internal liaison between Data Management and Company Project Management, Clinical Monitoring, and other functional groups. Monitors and communicates project progress to the customer and project team including use of project status reports and tracking tools/metrics. Plans, manages, and requests resource as required for assigned studies, as needed. Maintains a consistent, manageable workflow for Data Management project team by monitoring enrollment information and communicating with project team to actively influence data collection. Responsible for developing and maintaining the Data Management Plan (DMP) Responsible for a clean database by creating and resolving queries/discrepancies Responsible for developing eCRFs and specifications for receipt of external data, develops or ensures plans are in place for data validation/review, medical coding, query management, SAE reconciliation (as required) Regularly reviews project documentation to ensure that all documents are up-to-date, appropriately version controlled and that filing is up to date, including provision to client and filed in Trial Master File as appropriate
Responsibilities (cont.)
Coordinates user testing per User Test Plans developed for data entry screens, electronic edit checks, data listings, import/export programs, and medical coding during study build. Drives the development of the edit checks. Manages the database freeze and lock processes and procedures. Provides project specific training for CRAs (if required) and other project team members in project specific data management requirements. Plans for and creates necessary documentation to support internal and external audits; participates in such audits. Actively looks for and promotes process improvement opportunities and adopts an innovative mindset.Relationship & Interactions
Work with 3rd party vendors to ensure data delivery and timelines.
Influentially and assertively works with cross functional clinical team.
Work with site staff on query resolution and timely CRF completion
Plays an active role in interactions with data management functional leadership
Reporting to
Manager
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