Careers

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Current Openings

       Clinical Data Manager

Education Requirements: Master's degree in life sciences, computer science, or a related field; advanced degree preferred.

• Minimum of [5-6] years of experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry.

• Proficiency in database management systems (e.g., Oracle Clinical, Medidata Rave), data analysis tools (e.g., SAS, R), and programming languages (e.g., SQL, Python).

• Strong understanding of CDISC standards (SDTM/ADaM) and experience implementing CDISC-compliant data structures and metadata.

• Excellent attention to detail and problem-solving skills.

Job Description

Data Collection and Integration:

• Coordinate the collection and integration of clinical trial data from various sources, including electronic data capture (EDC) systems, laboratory systems, and external vendors.

• Responsible for preproduction, production and post-production CDM Activates

• Ensure timely and accurate data entry, validation, and reconciliation to maintain data integrity and completeness.

Database Management:

• Assist in the design, development, and maintenance of clinical trial databases, ensuring adherence to industry standards and regulatory requirements.

• Perform database programming tasks, such as schema design, data dictionary creation, and data validation checks.

Data Processing and Cleaning:

• Develop and implement data processing workflows to standardize, clean, and transform raw clinical trial data into analysis-ready datasets.

• Conduct data cleaning activities, including identifying and resolving discrepancies, outliers, and missing data.

Quality Control and Assurance:

• Conduct regular quality control checks to ensure the accuracy and consistency of clinical trial data.

• Perform data reviews, validations, and reconciliations to identify and address data discrepancies and inconsistencies.

Data Analysis Support:

• Provide support to biostatisticians and data analysts in performing statistical analysis and data visualization tasks.

• Generate periodic status reports for Weekly/ Monthly meeting with stakeholders.

Documentation and Reporting:

• Maintain accurate and up-to-date documentation of data management activities, including data management plans, data validation specifications, and data cleaning logs.

• Prepare regular progress reports, data summaries, and presentations for internal stakeholders, clients, and regulatory agencies as required

Regulatory Compliance:

• Ensure compliance with regulatory requirements, including ICH-GCP guidelines, FDA regulations, and other relevant standards, in all data management activities.

• Assist in preparing documentation for regulatory submissions and inspections, including data management plans and validation documentation.

       Manager-Regulatory Affairs

Education Requirements: Bachelor’s/ Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related field.

• Minimum of 5-7 years of experience in Regulatory Affairs, specifically in clinical trials and product registration.

• In-depth knowledge of regulatory requirements for clinical trials, IND, NDA, BLA submissions, and post-marketing regulations.

• Familiarity with eCTD submissions and regulatory compliance documentation.

• Understanding of import/export licensing processes, including regulatory approval for clinical trial materials.

Job Description

• Develop and implement regulatory strategies for clinical studies to ensure compliance with CDSCO, FDA, EMA, and other international regulatory bodies.

• Interpret and provide guidance on global regulatory requirements, including those for INDs, NDAs, and CTAs.

• Provide regulatory intelligence and strategic advice for project planning and execution.

• Lead the regulatory submission process, including eCTD (electronic Common Technical Document) preparation and management.

• Liaise with CDSCO and other regulatory agencies to address queries, resolve issues, and expedite approvals.

• Maintain a repository of regulatory submissions, approvals, and correspondences for audit readiness.

• Lead the preparation, review, and submission of high-quality regulatory dossiers, including INDs, NDAs, BLAs, CTAs, and MAAs.

• Oversee the application process for Import/Export Licenses required for investigational products, study materials, and laboratory supplies.

• Ensure timely and accurate submissions of project-related documents such as clinical study protocols, amendments, and investigator brochures to CDSCO and other authorities.

• Coordinate the preparation and submission of New Drug Applications (NDAs), Biological License Applications (BLAs), and Marketing Authorization Applications (MAAs).

• Monitor and manage the submission of SAE reports to CDSCO and other relevant regulatory authorities within prescribed timelines.

• Ensure compliance with regulatory requirements for pharmacovigilance, including periodic safety update reports (PSURs) and Development Safety Update Reports (DSURs).

• Manage the preparation, review, and submission of Clinical Study Reports (CSRs) to CDSCO and other regulatory bodies.

• Collaborate with clinical, quality assurance, pharmacovigilance, medical writing, and supply chain teams to align regulatory deliverables with overall project timelines.

• Build, mentor, and manage a team of regulatory professionals to ensure the delivery of high-quality regulatory services.

Apply today and be a part of our story

📧 Send your resume to hr@rclinicalsolution.com

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