Novotech is hiring for two clinical research positions in India: Clinical Data Programmer II and Senior Document Management Associate (SDMA). These roles focus on clinical data programming, clinical trial database management, Trial Master File (TMF) management, and quality control in clinical research.

Graduates from information science or life science-related fields can apply for the Clinical Data Programmer II position if they have at least two years of relevant experience. The Senior Document Management Associate role requires practical experience in TMF activities and more than two years of experience in a CRO or equivalent role.

Novotech Recruitment 2026 – Job Details

Positions Available at Novotech

1. Clinical Data Programmer II

Job Overview: The Clinical Data Programmer II will work within the Data Management department, handling clinical trial database programming, data review listings, data reconciliation, and database validation in compliance with Good Clinical Data Management Practices (GCDMP).

Key Responsibilities:

• Design, develop, test, and maintain clinical trial databases across different Electronic Data Capture (EDC) applications.
• Program data review listings and data reconciliation activities.
• Perform external data loads, including laboratory and ECG data.
• Coordinate with vendors to establish data transfer specifications and standards.
• Annotate Case Report Forms (CRFs) according to CDISC or sponsor-specific guidelines.
• Support data exchanges between clinical databases and other programming or reporting systems.
• Validate electronic systems, software, and clinical trial programs.
• Follow company SOPs, ICH-GCP requirements, and good programming practices.
• Participate in project meetings and support project leads as required.

Eligibility and Qualifications:

• Graduate in information science, a life science-related field, or a similar discipline.
• At least two years of experience in a similar role within a CRO or pharmaceutical company.

Required Skills:

• Clinical trial database programming and maintenance.
• Experience with EDC applications.
• Clinical data review listings and data reconciliation.
• External data transfers and vendor coordination.
• CRF annotation and CDISC guidelines.
• Clinical database validation and regulatory compliance.
• Ability to learn new programming languages, processes, and technologies.

2. Senior Document Management Associate (SDMA)

Job Overview: The Senior Document Management Associate will support clinical study teams in managing paper and electronic Trial Master Files (TMFs), conducting document quality control, maintaining inspection-ready documentation, and mentoring new Document Management Associates.

Key Responsibilities:

• Set up, receive, track, upload, and maintain paper and electronic TMF documents.
• Ensure documents meet essential document requirements and quality standards.
• Manage study documentation through systems such as SharePoint and electronic or paper TMFs.
• Conduct comprehensive document quality control reviews.
• Prepare TMF quality reports, monthly reports, checklists, and daily QC schedules.
• Ensure documents are filed accurately and on time according to ICH-GCP and applicable SOPs.
• Prepare TMFs for study closeout, audits, and regulatory inspections.
• Resolve internal quality control and audit findings.
• Coordinate with project teams to resolve document queries within stipulated timelines.
• Support interim eTMF exports and uploads for sponsors or third parties, where applicable.
• Mentor and train new Document Management Associates.
• Participate in clinical operations meetings and contribute to process and SOP development.

Eligibility and Qualifications:

• More than two years of experience in a CRO or an equivalent role.
• Practical experience handling paper or electronic Trial Master Files (eTMF).
• A background in the pharmaceutical, CRO, or healthcare industry is advantageous.

Required Skills:

• Trial Master File (TMF) management.
• Electronic Trial Master File (eTMF) documentation.
• Document filing, tracking, and quality control.
• ICH-GCP and SOP compliance.
• Audit and inspection readiness.
• Quality reporting and query resolution.
• Coordination with clinical project teams.
• Training and mentoring team members.

Application Details

Application Link For Clinical Data Programmer II

Application Link For Senior Document Management Associate