Clinical Data Manager III (India)

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-specific training as required
• Review and validate clinical data to ensure consistency, accuracy, integrity and completeness
• Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock) 
• Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
• Create and review project metric reports, status updates, study progress to Lead DM in order to share information on site performance issues, data trends and protocol non-compliance 
• Support and conduct Quality Review checks during study. As lead DM, may organize and lead Quality Review activities
• Assist in contracts negotiation and contracting process with vendors (EDC, IRT, eCOA) 
• 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 audits; 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.

To be successful you will possess:

• Minimum Educational Requirement: Preferably Life science graduate or equivalent qualification

• 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.
• Familiarization of data standards, preferably CDISC STDM.