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Requisition ID 31987BR
Title Principal 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 international study groups at other NN affiliates and NNAS, DM staff members in NN global DM community, and external vendors.
Reports to line of business (LoB) manager of Data Management (DM) within CTM. Accountable for actively participating in 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 & PERSONNEL DEVELOPMENT:
- Ensures compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
DEPARTMENTAL MANAGEMENT & STAFF DEVELOPMENT:
- Active mentorship of CTM staff to build talent across the department. Participates in continuous process improvement for function as a Subject Matter Expert (SME).
- May support and communicate functional, departmental or organizational initiatives.
- May support the maintenance of guidelines, training programs, policies and procedures for the functional locally.
- Accountable for providing data management documentations to support study activities.
- 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.
- Acts as primary contact in 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.
- Creates, reviews and utilizes study related tracking systems to determine and report status of clinical trial data and be responsible for the follow up to collect outstanding documents...cont.