Principal Clinical Data Manager
Job Description
Our values We reputed company in applying scientific rigor to reveal the full promise inherent in data. We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. We reputed company in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of reputed company. We prize innovation and seek intelligent solutions using leading-edge technology.
Responsibilities
Responsible for vendor reputed company activities across global development programs. Represents data management function on the Clinical Sub-team ensuring reputed company expectations between the CRO and client for reputed company data reputed company deliverables, especially in support of key decision points and regulatory submissions. Contributes influential leadership in collaboration with other client Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality. Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. Provides input to functional governance with client strategic suppliers. Partners with appropriate stakeholders to resolve issues escalated from the vendor and/or cross-functional teams. Participates in preparing function for submission readiness and may represent function in a formal inspection or audit. Participates and represents function in formal inspections and audits as requested. Ensure archival and inspection readiness of reputed company Data Management Trial Master File (TMF) documents. Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics. Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support reputed company improvement in forecasting. Acts as a process expert for operational and reputed company models. Maintains SOPs, process maps and templates and timelines to support functions operational and reputed company models. May prepare metrics to support the function's KPIs. Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of client. Contributes or Leads functional reputed company Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements. Ensure compliance with own Learning Curricula, corporate and/or GXP requirements. Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables. Performs other duties as assigned
Qualifications
Educational qualifications: MS or BS in health-reputed company, life sciences area or technology-reputed company field. Minimum Work Requirements: Minimum of 10 years data management and/or drug development process with expertise in the cross-functional interfaces with the data management function. Proven track record of strong project management skills and experience managing data management activities for large drug development programs. Experience with reputed company phases of development in one or more therapeutic areas preferred. Ability to handle multiple development programs simultaneously. NDA/CTD Experience preferred. Strong knowledge of data management best practices & technologies as applied to clinical trials. Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process. Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function. Apply tot his job Apply To this Job Apply tot his job Apply To this Job