Clinical Data Manager II

LE1730 Heron Health Pvt Ltd; Hyderabad; On-site; INR 1,500,000 - 2,100,000; Full time

Benefits offered by this job

Medical plan

Personal Accident Insurance

Life Insurance

Critical illness cover

Provident fund 12%

Gratuity scheme

Internal growth programs

Job summary

Perceptive is on a mission to accelerate clinical research, seeking a Clinical Data Manager II to act as an end-to-end data custodian. You will manage data accuracy, completeness and regulatory compliance while supporting study teams throughout data lifecycle.

The role includes designing CRFs and databases, creating Data Management Plans, monitoring timelines, and preparing data extracts for sponsor deliverables. Fluent English and Life Science background are required.

Qualifications

• Bachelor’s Degree in Life Science and 5-7 years practical work experience in a clinical or technical setting.
• Demonstrated experience with clinical data management systems and working with research support or clinical teams.
• English: Fluent

Responsibilities

• Primary role in design of project databases, integration of data from multiple sources, and reporting of key study data metrics.
• Design study CRFs and databases utilizing eCRF library.
• Create study Data Management Plan and deployment roadmap.
• Monitor study timelines and communicate risk.
• Develop database edits, rules, and derivations.
• Prepare tracking reports and metrics.
• Facilitate study team involvement in database development.
• Prepare data extracts and processing for sponsor deliverables.
• Communicate with sponsors regarding study data processes, endpoints, and data management.

Skills

Technical project management

Clinical data management systems

Team collaboration

English fluency

Education

Bachelor’s degree in Life Science

Tools

CDMS software

Job description

We’re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you.

• HEALTH: - Medical plan for you and your dependents.
• - Personal Accident Insurance
• - Life Insurance
• - Critical illness cover
• WEALTH: - Salary structure and Flexi basket
• - Provident fund of 12%
• - Gratuity scheme
• YOURSELF: Internal growth and development programs & trainings

Clinical Data Manager II

The Clinical Data Manager II is an end-to-end data custodian and plays a key role in managing data and ensuring its accuracy, completeness, and compliance with regulatory standards while providing data management support to study teams. The Clinical Data Manager excels in defining overall data standards, data collection requirements, data import, extraction, reporting, and analysis methods. The incumbent shall demonstrate a strong working knowledge of Good Clinical Data Management Practices.

Key Responsibilities

• Primary The Clinical Data Manager II plays an essential role in the efficient design of project databases, the integration of data from multiple sources, and the reporting and analysis of key study data metrics. The incumbent will recommend and drive solutions for database design and data reporting. This role is critical for meeting sponsor study data endpoints and requirements.
• Design study CRFs and databases utilizing eCRF library
• Create study Data Management Plan and deployment roadmap
• Monitor study timelines and communicate risk
• Develop database edits, rules, and derivations
• Prepare tracking reports and metrics
• Facilitate study team involvement in database development
• Prepare data extracts and processing for sponsor deliverables
• Communicate with sponsors regarding study data processes, endpoints, and overall data management process
• Other Carryout any other reasonable duties as requested.

Functional Competencies (Technical knowledge/Skills)

• Technical project management and oversight
• Task creation and tracking via ticketing software
• Proficient with clinical data management systems
• Experience working with research support or clinical team
• Experience, Education, and Certifications Bachelor’s Degree in Life Science (Biology, Medical Technology, Research Psychology, Math or Health Science or equivalent experience in a related field 5-7 years practical work experience in a clinical or technical setting Demonstrated experience in team settings to achieve goals Demonstrated experience with clinical data management systems Experience working with research support or clinical team English: Fluent Come as you are.

We’re proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

At Perceptive, we enable the world’s pharmaceutical, biotech, and clinical research organizations to rapidly discover and advance life-changing treatments. Together, our global team delivers unmatched scientific and technological expertise, global operational experience, and end-to-end solutions to help the global research community realize tomorrow’s new therapies.