Clinical Data Manager I

Clinical Data Manager I

Allucent | Chennai, TN, IN

Posted a month ago

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Description

The Clinical Data Manager I (CDM) leads and coordinates Data Management (DM) activities from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.
The CDM I works on studies with minimal supervision from a CDM II or senior CDM.
The CDM I is a member of the Data Management staff.
Serve as primary contact for DM with all relevant parties both internally (e.g. Project Management, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, external vendors, investigational sites
Plan and project the resources required including management of tasks, timelines, risk and quality
Keep track on budget, forecasts and manage changes of scope requests
Participate in the review of study documents (e.g. protocol, (electronic) case report forms (eCRFs), safety plans/manuals and statistical analysis plan)
Provide support on clinical study database set-up, including eCRF design and database validation requirements
Develop, review and maintain project-specific DM documents including data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements
Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks
Create training materials for EDC users and provide project-specific training as required
Review and validate clinical data to ensure consistency, accuracy, integrity and completeness
Create data cleaning plan in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance etc.
Perform and/or coordinate various data transfers and data reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
Assist in medical coding tasks as assigned
Assist in training of other DM personnel and project teams
Help to align data management and clinical programming best practices, standards and conventions within the company
Explore and propose initiatives for improving efficiency
Participate in internal and external audits
Maintain documentation on an ongoing basis and ensure that all filing is up to date
Manage the database implementation, lock and close-out processes and procedures
Recognize and solve potential problems and evaluate effectiveness
Participate in conference calls and/or meetings with vendors and sponsors

Qualifications
Requirements

Life science, healthcare and/or related field degree
Minimum 2-4 years of relevant work experience
Minimum 2-4 years of experience in drug development and/or clinical research
Basic knowledge of ICH-GCP(R2), GDPR/HIPAA and applicable (local) regulatory requirements
Good understanding of CDISC data conventions
Good understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation)

Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies
Proficiency with various computer applications such as Word, Excel, and PowerPoint required
Strong written and verbal communication skills including good command of English language
Representative, outgoing and client focused
Ability to work in a fast-paced challenging environment of a growing company
Administrative excellence
Eye for detail, strong technical, analytical and problem-solving skills
Strong project management skills
Ability to translate guidelines, rules and regulations in clear and usable recommendations