Allucent
biopharmaceutical
ClinicalDataManagerIII
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“Clinical Data Manager III at Allucent. Skills: clinical data management, database design, data cleaning, data validation, regulatory requirements. manage and coordinate DM deliverables 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”
What You'll Achieve.
ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting
Industry & Context.
Demonstrated proactiveness, problem-solving, analytical, organizational and time management skills; Recognize and solve potential problems and evaluate effectiveness
This is not a remote position and we are looking for a candidate who can work from the office (Chennai Location)
What They're Looking For.
Must Have
6+ years’ experience in clinical data management experience within Contract Research Organization (CRO), Pharmaceutical or biotech industries, Proven knowledge of clinical data management processes and clinical database systems, including Electronic Data Capture applications, Good communication skills written and verbal, Effective working knowledge of Microsoft Office Suite including Word and Excel, Demonstrated proactiveness, problem-solving, analytical, organizational and time management skills, Demonstrated flexibility and ability to work well in a fast-paced growing organization, Demonstrated ability to work in a global team environment, Demonstrates a basic understanding of Clinical Trials and the flow of data, Demonstrated ability to be compliant with ICH-GCP/regional regulatory guidelines and POI SOPs, Comprehension of study documentation standards including Trial Master File organization and archival processes
Nice to Have
Familiarization of data standards, preferably CDISC STDM
What You'll Do.
manage and coordinate DM deliverables 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
Lead and serve as primary contact for DM with all relevant parties both internally and externally
Plan and project the resources required including management of tasks
Monitor tasks against and keep track on budget
identify and trigger changes of scope requests
review and maintain project-specific DM documents
Lead and coordinate the development of clinical study database set-up
Participate in the review of study documents
lead and coordinate the review of (electronic) case report forms (eCRFs)
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
integrity and completeness
Create data cleaning strategy in consultation with applicable functional groups and oversee data releases
Perform and/or coordinate various data transfers and reconciliation activities
Create and review project metric reports
Support and conduct Quality Review checks during study
Assist in contracts negotiation and contracting process with vendors
Manage the database maintenance
lock and close-out processes and procedure
Participate in conference calls and/or meetings with vendors and sponsors
Recognize and solve potential problems and evaluate effectiveness
Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date
Plan and create necessary documentation to support internal and external may participate in such audits assigned
Help to align data management and clinical programming best practices
standards and conventions within the company
Propose and support initiatives for improving efficiency
How You'll Work.
Team & Collaboration
Lead and serve as primary contact for DM with all relevant parties both internally (e. g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e. g. sponsors, vendors (EDC, external data), and investigational sites); work in a global team environment; Participate in conference calls and/or meetings with vendors and sponsors; Help to align data management and clinical programming best practices, standards and conventions within the company
Communication Scope
Good communication skills written and verbal
Process & Methodology
Plan and project the resources required including management of tasks, timelines, risk and quality, Monitor tasks against and keep track on budget, forecasts, identify and trigger changes of scope requests, Manage the database maintenance, lock and close-out processes and procedure
Full Job Description
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for Clinical Data Manager III (CDM III) to join our A-team. As CDM III at Allucent, you will manage and coordinate DM deliverables 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. **PLEASE NOTE: This is not a remote position and we are looking for a candidate who can work from the office (Chennai Location).** **In this role your key tasks will include:** * Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites) * Plan and project the resources required including management of tasks, timelines, risk and quality * Monitor tasks against and keep track on budget, forecasts, identify and trigger changes of scope requests * Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements * Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements * Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs) * Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks * Create training materials for EDC users and provide project-spe
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