Associate Manage Clinical Data Management

SIRO Clinpharm Pvt. Ltd.; India; Teletrabalho; INR 1 500 000 - 2 300 000; Tempo integral

Resumo da oferta

SIRO Clinpharm Pvt. Ltd. is seeking an Associate Manager, Clinical Data Management to join the remote team. You will ensure archival, inspection readiness, and manage data management deliverables across trials.

The role requires strong project management, knowledge of FDA/ICH regulations, and experience with CDISC standards. You will collaborate across functions to maintain data quality, timelines, and budget control while promoting process improvements.

Qualificações

• 6+ years of data management/drug development experience

Responsabilidades

• Prepare function for submission readiness.
• Ensure archival and inspection readiness of all Data Management TMF documents.
• Plan and manage external Data Management budgets and timelines to ensure accuracy.
• Act as a process expert for operational and oversight models.
• Prepare metrics to support function’s KPIs.
• Contribute to Continuous Improvement initiatives and cross-functional alignment.
• Ensure data quality across databases and on-time delivery.

Conhecimentos

Data management

Project management

FDA & ICH regulations

CDISC standards

Clinical trials

Budget forecasting

Ferramentas

Microsoft Office

Clinical data management systems

Coding tools

Descrição da oferta de emprego

Role: Associate Manager, Clinical Data Management

Location: Remote Working

Job Description

Participates in preparing function for submission readiness.

• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. * Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
• Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting. * Acts as a process expert for operational and oversight models.
• May prepare metrics to support the function’s KPIs.
• 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.
• Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables
• Champions and adopts technology improvements and tools for use in clinical data management processes.
• Ensure compliance with own Learning Curricula, corporate and/or GXP requirement. Performs other duties as assigned.

Key Accountabilities

Preferred 6 plus years of experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.

• Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
• Experience with all phases of development in one or more therapeutic areas preferred.
• Ability to handle multiple development programs simultaneously.
• NDA/CTD Experience 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.
• Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
• Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.

Special Skills/Abilities

• Advanced knowledge of office software (Microsoft Office).
• Experience with budget planning & management.
• Strong knowledge of relational databases and experience using multiple clinical data management systems.
• Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
• Ensures adherence to functional budget, and provides timely updates to manager regarding additional, potential spend or cost savings.
• Expert knowledge of CDISC standards, SDTM preferred. Good experience leading standards selection and implementing in clinical trials is ideal.
• Expert knowledge of general of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.