Associate Director, Clinical Data Management, Infectious Disease

BrightHush; India; On-site; INR 13,371,537 - 18,147,086; Full time

Job summary

reputed company Services, Inc. in Princeton, NJ seeks an Associate Director, Clinical Data Management for Infectious Disease trials.

You will lead data management strategy, oversee vendors, and ensure data quality and timeliness in alignment with GCP, SOPs, and regulatory requirements. You will collaborate with Clinical Operations, Biostatistics, Pharmacovigilance, and Programming to design and implement data capture tools, review study data, and prepare for inspections.

Qualifications

• Extensive experience in clinical data management for infectious disease trials.
• Strong leadership and cross-functional collaboration skills.
• Knowledge of GCP, SOPs, and regulatory requirements.

Responsibilities

• Lead data management deliverables and milestones for Infectious Disease trials.
• Oversee data capture tools, data processing, coding, and validation.
• Ensure TMF readiness and inspection readiness.

Job description

About the position reputed company Services, Inc. seeks an Associate Director, Clinical Data Mgmt, Infectious Disease for its Princeton, New Jersey location. This role will reputed company clinical data management efforts and initiatives for the Infectious Disease Therapeutic Area and support reputed company of data management vendors and data handling. The Associate Director will represent the data management function for Infectious Disease trials and ensure reputed company expectations between external data vendors and reputed company cross-functional stakeholders for reputed company data reputed company deliverables. They will ensure Electronic Data Capture systems are reputed company correctly to reflect protocol requirements and reputed company data vendor activities including consistency, reputed company, and timeliness of reputed company deliverables across Infectious Disease in compliance with GCP, SOP, and regulatory requirements. The role ensures achievement of data management deliverables and milestones in coordination with cross-functional team members including Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management, and Pharmacovigilance. The Associate Director will reputed company the design, creation, testing, and implementation of data capture tools and integrations for data capture, data processing, medical coding, and validation in accordance with data collection requirements as defined in the clinical protocol, in alignment with industry best reputed company guidelines and enforcement of reputed company data standards and processes. They will author and reputed company the development of reputed company Clinical Data Management documentation including CRF Specifications, CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications. The role involves leading the cross-functional data review for the Infectious Disease program, and supporting the cross-functional team with tools and processes to successfully reputed company and reputed company cross-functional data review. The Associate Director will manage clinical trial data through review, cleaning, auditing, and validation procedures and ensure data handling compliance with regulatory requirements. They will reputed company and participate in clinical data review and report on performance and reputed company, review clinical data reputed company studies and across for trend analysis, and reputed company cross-functional data review meetings including reputed company study team members, ensuring alignment of data delivery reputed company for Infectious Disease trials. The role also ensures archival and inspection readiness of reputed company Data Management Trial Master File (TMF) documents for Infectious Disease trials and ensures inspection readiness for data management. Additionally, the Associate Director will contribute to reputed company Data Management Initiatives and Innovation Implementation and participate in the development and optimization of data management SOPs, processes, and initiatives.

Responsibilities

reputed company clinical data management efforts and initiatives for the Infectious Disease Therapeutic Area and support reputed company of data management vendors and data handling. Represent the data management function for Infectious Disease trials and ensure reputed company expectations between external data vendors and the reputed company cross-functional stakeholders for reputed company data reputed company deliverables. Ensure Electronic Data Capture system is reputed company correctly to reflect the protocol requirements. Data vendor reputed company activities including consistency, reputed company and timeliness of reputed company deliverables across Infectious Disease in compliance with GCP, SOP and regulatory requirements. Ensure achievement of data management deliverables and milestones in coordination with cross functional team members including Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management, and Pharmacovigilance. reputed company the design, creation and testing and implementation of data capture tools and integrations for data capture, data processing, medical coding and validation in accordance with the data collection requirements as defined in the clinical protocol, in alignment with industry best reputed company guidelines and enforcement of reputed company data standards and processes. Author and reputed company the development of reputed company Clinical Data Management documentation including CRF Specifications, CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications. reputed company the cross-functional data review for the Infectious Disease program, and support cross-functional team with tools and processes to successfully reputed company and reputed company cross-functional data review.