Medpace is hiring for 5 positions across Clinical Operations and Biostatistics in India. The openings are based in Navi Mumbai/Mumbai and Delhi, with opportunities covering regulatory submissions, study start-up, site payments, and SAS programming.

Job Details

Positions Available

1. Regulatory Submissions Coordinator (Senior/Experienced)

Location: Navi Mumbai, India
Department: Site Activation & Maintenance
Job ID: 12919
Work Arrangement: Full-time, office-based, with hybrid work arrangements based on eligibility

Responsibilities

• Perform country-level activities required for investigative site activation across clinical trial phases.
• Prepare, review, and submit regulatory documentation.
• Communicate with global study teams regarding study progress.
• Identify and mitigate risks related to site activation.
• Provide guidance on ethics and regulatory submissions.
• Review and finalize essential site activation documents.
• Coordinate Ethical and Regulatory submission activities.
• Communicate directly with investigative sites during study start-up and activation.
• Ensure submissions comply with applicable regulations and guidance.
• Advise sponsors on changing regulations and compliance requirements.
• Track submissions and ensure timely document filing.

Qualifications

• Bachelor’s degree in a science field.
• More than 4 years of regulatory submissions experience in clinical research, preferably with a CRO.
• Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Authorities, including CDSCO and DCGI.
• Experience formulating responses to regulatory queries.
• Willingness to travel to Delhi is a plus.
• Strong oral and written communication skills.
• Strong local regulatory experience is required for the Regulatory Submissions Coordinator level.

2. Study Start-Up Submissions Manager

Location: Delhi, India
Department: Site Activation & Maintenance
Job ID: 12312
Work Arrangement: Full-time, remote-based

Responsibilities

• Follow up closely on clinical trials submitted to DCGI.
• Conduct face-to-face visits when required.
• Facilitate meetings with DCGI and support consultation processes.
• Manage and execute local and Regional APAC start-up activities.
• Interact independently with sponsors, sites, IRBs/Ethics Committees, and regulatory agencies.
• Perform quality checks on submission and site essential documents.
• Prepare and approve informed consent forms.
• Review regulations and develop solutions for start-up issues.
• Present during bid defenses, capability meetings, and audits.

Qualifications

• Bachelor’s degree.
• More than 8 years of regulatory submissions experience in clinical research, preferably with a CRO.
• Experience may include CRA or project management experience.
• Local and Regional APAC experience is mandatory for the RSM level.
• Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Authorities.
• Experience formulating responses to regulatory queries.
• Strong oral and written communication skills.

3. Site Payments Processor

Location: Navi Mumbai, India
Department: Site Activation & Maintenance
Job ID: 12313
Work Arrangement: Full-time, office-based

Responsibilities

• Execute accounts payable and site payment data-entry activities for assigned studies.
• Manage system requirements for tracking and administering site payments.
• Process and calculate site payments.
• Handle project and site reporting and requests.
• Coordinate site-specific agreements and amendments.
• Map site payees.
• Code, track, and reconcile site invoices against applicable data sources.

Qualifications

• Bachelor’s degree in a related field.
• At least 1 year of related experience in finance, treasury, accounting, or business.
• Proficiency in Microsoft Office programs.
• Strong organization and time-management skills.
• Ability to prioritize tasks while meeting deadlines.
• High attention to detail and accountability.
• Professionalism and confidentiality.

4. SAS Programmer

Location: Navi Mumbai, India
Department: Biostatistics
Job ID: 12315
Work Arrangement: Full-time, office-based

Responsibilities

• Write SAS programs for analysis datasets, tables, listings, and figures.
• Program, validate, and maintain mapped databases using SAS.
• Program edit checks for external data.
• Coordinate communication and issues with Data Management regarding database specifications and data transfers.

Qualifications

• Bachelor’s or Master’s degree in mathematics, statistics, health informatics, data science, computer science, or life sciences.
• SAS certification.
• SAS knowledge.
• 1–2 years of experience is preferred.
• Good English written and communication skills.

5. Experienced SAS Programmer

Location: Navi Mumbai, India
Department: Biostatistics
Job ID: 12319
Work Arrangement: Full-time, office-based

Responsibilities

• Propose and develop specifications for new projects.
• Serve as a project team leader.
• Develop SAS programs for analysis datasets, tables, listings, and figures.
• Set up, validate, and maintain mapped databases.
• Integrate external data and develop associated edit checks.
• Independently write high-quality SAS programs.
• Validate and maintain mapped databases and external data integrations.

Qualifications

• Bachelor’s or Master’s degree in mathematics, statistics, health informatics, data science, computer science, or life sciences.
• 5+ years of SAS experience.
• Excellent knowledge of CDISC standards.
• SAS certification.
• Thorough understanding of the pharmaceutical industry and federal regulations regarding electronic records.
• Excellent analytical, written, and oral communication skills.
• Good English written and communication skills.

Required Skills

Depending on the position, relevant skills include:

• Regulatory submissions
• Clinical research
• CDSCO and DCGI submissions
• Ethics Committee submissions
• Clinical trial site activation
• Study start-up
• Regulatory query responses
• APAC regulatory experience
• Clinical operations
• Site payments
• Accounts payable
• Microsoft Office
• SAS programming
• CDISC standards
• Mapped database programming
• External data integration
• Data management coordination
• Pharmaceutical regulations
• Written and verbal communication

How To Apply