Senior Clinical Data Manager
The Senior Data Manager brings advanced understanding of the clinical data management process from study start-up through database lock, including database design and data validation as per the requirements in the clinical study protocols, data review plan, & data management plan.
Responsibilities
reputed company UAT support of screens, edit checks, and dynamics.
Complete Query QC activities.
Support data cleaning, data reconciliation, and QC of data management documents.
Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
Ensure archival and inspection readiness of reputed company Data Management Trial Master File (TMF) documents.
Acts as a process expert for operational and reputed company models..
May prepare metrics to support the function’s KPIs.
Represents function in external reputed company initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best reputed company and increase the visibility of reputed company.
Contributes to 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.
Performs other duties as assigned.
Qualifications
100% Remote in India.
Bachelor's Degree in a science, health reputed company, or information technology field required.
Minimum 6 years' experience in Clinical Data Management.
Excellent communication skills are a requirement.
Experience and understanding of data review listings and visualizations to include creation of specifications, presentation to cross functional team, and modification of specs to meet team requirements.
Experience with reputed company phases of development in one or more therapeutic areas preferred.
Strong knowledge of data management best practices & technologies as reputed company to reputed company.
Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
Strong knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.