Novotech is hiring a Senior Clinical Data Associate – Medical Coding in Bangalore, India. The role focuses on clinical data management activities, including data review, query management, external data reconciliation, database validation, and mentoring junior Clinical Data Associate (CDA) staff.

Job Details

Positions

Senior Clinical Data Associate – Medical Coding

The position is part of the project team and reports to the Biometrics Project Manager. The role involves independently supporting clinical studies through data acquisition, validation, reconciliation, and quality-focused data management activities.

Responsibilities

• Perform data management activities including data review, query management, and external data reconciliation.
• Track CRF pages and other study data documents received and entered.
• Track data queries and provide proactive metrics reporting to study team members.
• Prepare and validate database specifications and edit-check specification procedures.
• Maintain accurate and timely filing of CRFs, DCFs, and other data management documents.
• Support accurate and timely archiving of study DMF, CRF Files, and Data Query Master File.
• Perform user acceptance testing of data entry screens and consistency checks of clinical study databases.
• Mentor junior CDA staff.
• Represent the Data Management Team on CDA-related matters, including investigator meetings and audits.
• Support CDM activities where appropriate.
• Act as an internal DM Lead on studies when required.
• Liaise with external service providers on data management projects.
• Participate proactively in project meetings.
• Prepare agendas and meeting minutes for data management team meetings.
• Lead or facilitate CDA-related topics and discussions and prepare topic presentations.
• Provide general administrative and project management support to the Data Management Team.
• Follow company quality policies, procedures, SOPs, ICH-GCP guidelines, GCDMP guidelines, and applicable local regulatory requirements.
• Contribute to process improvement initiatives within the Data Management Team.
• Participate in industry forums, conferences, and professional associations for professional development and promotion of Novotech’s image in the industry.

Eligibility & Qualifications

Candidates should meet the following requirements:

• Graduate in a clinical or life sciences related field.
• Relevant experience or qualifications in allied professions may also be considered.
• 2–4 years of experience working as a Clinical Data Associate or in an equivalent role in the pharmaceutical industry or a related field.

Required Skills

The role requires experience or capability in areas such as:

• Clinical data management
• Data review and validation
• Query management
• External data reconciliation
• CRF and study data document tracking
• Database specification and edit-check validation
• Clinical study database testing
• Data management documentation and archiving
• Project coordination and administrative support
• Mentoring junior staff
• Communication with internal teams and external service providers
• Process improvement
• ICH-GCP and GCDMP compliance

Application Details

Application Link