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Requisition ID 33191BR
Title Senior Clinical Data Analyst
Job Category Clinical Trial Management
Job Description PURPOSE:
Responsible for the support of assigned trials in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within CMR, as well as DM staff members in NN global DM community.
Reports to Associate Manager / Manager / Senior Manager of Data Management (DM) within CTM. Accountable for actively participating in multiple cross-functional teams locally and/or globally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or function.
COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
- Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
- May participate in continuous improvement processes for function as Subject Matter Experts (SME).
- Accountable for the quality and maintenance of clinical Data Management System (OC, EDC) in accordance with NNI SOPs. Performs ongoing data cleaning and reviews to assure quality of the data and compliance with NNI SOPs, GCP and ICH Guidelines.
- Accountable to provide data management documentations to support study activities.
- Act as primary DM for assigned studies to convey project information, answer questions and report to study group (including ISG meetings) during trial conduct and closure phases.
- Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of DM documentation.
- Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and NNI SOPs.
- Collaborates with RTM / LTM / PM to obtain/share trial specifics issues across all study sites concentrating on areas related to data quality, site performance and metrics. Responsible for communicating issues in accordance with the project or CTM escalation pathway
- Create, review and utilize study related tracking systems to determine and report status of clinical trial data and responsible for the follow up to collect outstanding documents and resolve issues.
- Ensure DM documents are maintained during the lifecycle of assigned project in collaboration with project team locally and globally.
- Maintain trial Data Flow Plan and responsible for carrying out DM tasks according to data flow plan for assigned trials.
- Provides quality overview and consistency check on all clinical data and DM trial documents (DHP, TDR, etc.)
- Responsible to assure adequate and appropriate dissemination of information according to the study specific communication plan between DMs, in house and regionally based staff locally and globally to ensure project success...cont. - See more at: http://www.hirelifescience.com/senior-clinical-data-analyst-job/princeto...