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Cytel Statistical Software & Services

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4.4

based on 48 Reviews

1 Cytel Statistical Software & Services Senior Clinical Data Manager Job

Senior Clinical Data Manager

Cytel Statistical Software Services Pvt. Ltd.

4.4

based on 48 Reviews

6-8 years

Kolkata, Mumbai, New Delhi + 4 more

1 vacancy

Senior Clinical Data Manager

Cytel Statistical Software & Services

posted 4d ago

Job Role Insights

Flexible timing

Key skills for the job

Cron Operations Information Technology Clinical Data Management Compliance Clinical Trials

+ 1 more

Job Description

Bachelors Degree in a science, health related, 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 Elluminate

This is a must have

Experience with all phases of development in one or more therapeutic areas 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

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

Represents data management function by being front facing with the cross functional study team

Creates Data Review listings and visualization specifications, presents to cross functional team, takes feedback and makes required changes

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 resolves issues escalated from the vendor and/or cross-functional teams

Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents

Complete Query QC activities

Provide UAT support of screens, edit checks, and dynamics

Acts as a process expert for operational and oversight 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 to functional Continuous 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

Employment Type: Full Time, Permanent

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