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Greetings from HCL Technologie!

About the Company

HCL Technologies is a global technology company that helps enterprises reimagine their businesses for the digital age. Our mission is to deliver technology solutions that drive business transformation and create value for our clients.

About the Role

We are looking for a talented individual to join our team and contribute to our mission of delivering innovative technology solutions.

Responsibilities

• Bachelor’s degree in Life Sciences, Computer Science, or related field.
• 6+ years of experience in clinical data testing and validation.
• Perform UAT for CRF screens, database edit checks, and exceptional reports/listings.
• Test clinical study setup configurations including protocol parameters, visit schedules, and form designs.
• Validate external data acquisition (Lab, ECG, PK/PD) and ensure accurate processing.
• Collaborate with Clinical Data Scientists and Study Data Managers to understand study scope and expectations.
• Strong experience with clinical study setup and CDMS platforms and CTMS
• Review edit check specifications; write and execute UAT scripts.
• Conduct QC on metadata listings and peer review of programming checks.
• Support automation tool validation and standardization of test scripts.
• Ensure consistent use of clinical data standards across programs and repositories.
• Work with Clinical Data Management Systems (e.g., Medidata Rave, Oracle InForm) to validate database builds and data flows.
• Ensure compliance with GxP/GcP and internal SOPs.
• Document and share study-related testing deliverables and lessons learned
• Solid understanding of SDLC, validation methodology, and document management

Qualifications

• Bachelor's degree in Computer Science or a related field.
• Relevant certifications are a plus.

Location - PAN INDIA

Pay range and compensation package

The compensation package will be competitive and commensurate with experience.

Equal Opportunity Statement

HCL Technologies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Interested candidate please drop mail to " "

Regards.

Suganya Periyasamy

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Job Role : Clinical Research Associate - Study Personnel (Toxicology & Efficacy)

Location: Dholka, Gujarat

Job Responsibilities :

1. Request for required no. of animals

2. Observe the study animals for clinical signs, functional observation battery and

mortality

3. Receipt, storage and handling of chemicals, reagents and solutions

4. Dose preparation and dosing of animals via different routs

5. Weighing of animals, feed consumption, body temperature, dermal observations

6. Randomization of study animals

7. Perform pharma-efficacy studies like batch release test i.e., Pyrogen test, Abnormal

toxicity test, Potency assays, nodule test etc.

8. Blood collection, separation and storage of samples

9. Preparation of study reports

10. Conduct of study, data collection, compilation and verification.

11. Collection of sample(s) / Specimen(s).

12. Preparation and verification of report.

13. To participate in Genotoxicity study

14. Data entry from raw data to computer application and further analysis

15. Co-operate during internal, RQA & sponsor audits of study plans, studies, data,

reports etc.

16. To participate in standardization of new toxicity study

17. Ensure proper labeling of containers (test item, samples etc.)

Documentation:

1. To document deviation from SOP or study plan and communicate directly with SD.

2. Recording raw data promptly and accurately and in compliance with Principles of

GLP.

3. Maintenance of internal records as per in-house SOPs and GLP

4. Update and maintain training records

5. Ensuring the availability of various monitoring certificates such as feed, water,

bedding material, health etc.

6. Request for the issuance of controlled / uncontrolled document and maintain the

documentation

7. Prepare / revise the SOPs as and when required in accordance with in-house SOP

8. Archive the documents as per in-house SOPs when applicable

9. Document the deviation from study plan or SOP and report the incident to SD or

HOS.

10. Record the raw data as and when activities are performed, verify the data and

calculation.

11. Results compilation and analysis

Instrument handling and maintenance:

1. Operate the instruments in accordance with respective instrument SOP, monitor

calibration & maintenance of instrumentation in lab

2. Perform the calibration / maintenance of instruments as per in-house SOP

• Monitor clinical trial sites to ensure protocol adherence and regulatory compliance.
• Conduct site initiation, routine monitoring, and close-out visits.
• Perform source data verification and resolve data discrepancies.
• Ensure all study-related documentation is accurate and up-to-date.
• Train and support site staff on study procedures and GCP guidelines.
• Oversee patient safety and report adverse events as required.
• Build and maintain strong relationships with investigators and site personnel.
• Identify and escalate study conduct issues and risks.
• Manage study supplies and investigational product at sites.
• Contribute to the preparation of study reports and regulatory submissions.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical research role.
• In-depth knowledge of GCP, FDA regulations, and other relevant guidelines.
• Experience with various therapeutic areas is a plus.
• Strong organizational, time management, and problem-solving skills.
• Excellent written and verbal communication abilities.
• Proficiency in clinical trial management software and EDC systems.
• Ability to travel to clinical sites as required.
• Detail-oriented with a commitment to data accuracy and integrity.
• Ability to work effectively in a hybrid work environment.

• Conduct site initiation, routine monitoring, and close-out visits.
• Verify the accuracy and completeness of clinical trial data collected at sites.
• Ensure adherence to study protocols, GCP, and applicable regulatory requirements.
• Manage communication between study sites and the core study team.
• Identify, resolve, and escalate site-related issues and discrepancies.
• Train site staff on study procedures and regulatory compliance.
• Review and ensure the proper maintenance of site regulatory files (e.g., Investigator Site Files).
• Prepare monitoring reports and provide feedback to study teams and management.
• Oversee drug accountability and inventory management at trial sites.
• Ensure timely enrollment of subjects and adherence to recruitment targets.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 2-3 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
• Thorough understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Experience with electronic data capture (EDC) systems and other clinical trial software.
• Excellent organizational, time management, and problem-solving skills.
• Strong written and verbal communication abilities.
• Ability to travel to clinical trial sites as required (up to 60% of the time).
• Attention to detail and commitment to data integrity.
• Ability to work independently and as part of a team.
• Phlebotomy or basic medical procedure skills are a plus.

• Site selection, initiation, monitoring, and close-out visits.
• Ensuring compliance with study protocols, standard operating procedures (SOPs), and regulatory guidelines (e.g., FDA, ICH GCP).
• Verifying the accuracy and completeness of source documents and case report forms (CRFs).
• Managing study supplies and investigational product at clinical sites.
• Serving as the primary point of contact for investigators and site staff.
• Resolving data discrepancies and ensuring timely query resolution.
• Preparing and submitting regulatory documentation as required.
• Identifying and reporting adverse events and serious adverse events (SAEs) in a timely manner.
• Conducting data reviews and audits to ensure data integrity.
• Maintaining accurate and up-to-date trial documentation in electronic trial master files (eTMF).
• Building and maintaining strong working relationships with study personnel, ethics committees, and regulatory authorities.
• Troubleshooting and resolving site-specific issues to ensure smooth trial conduct.
• Contributing to the development and review of study-related documents, such as protocols and informed consent forms.
• Participating in team meetings and providing regular updates on site progress and challenges.

• Bachelor's degree in a life science, nursing, or a related field. A Master's degree is preferred.
• Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical or biotechnology industry.
• In-depth knowledge of clinical trial processes, GCP, and regulatory requirements.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Excellent understanding of medical terminology and data management principles.
• Strong organizational and time-management skills, with the ability to manage multiple projects simultaneously.
• Exceptional interpersonal and communication skills, both written and verbal.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to study sites as required.
• A proactive and problem-solving attitude.

• Lead and manage all aspects of clinical research studies, from initiation to close-out.
• Develop and manage study budgets, track expenses, and ensure financial compliance.
• Recruit, train, and supervise clinical research staff, including CRAs and study coordinators.
• Ensure all research activities comply with Good Clinical Practice (GCP), FDA regulations, and other applicable guidelines.
• Oversee the informed consent process and ensure ethical conduct of research.
• Coordinate with Principal Investigators to ensure study protocols are followed accurately.
• Manage study documentation, including source documents, case report forms (CRFs), and regulatory binders.
• Liaise with Institutional Review Boards (IRBs)/Ethics Committees for protocol submissions and approvals.
• Monitor study progress, identify potential issues, and implement corrective action plans.
• Facilitate site visits from sponsors, auditors, and regulatory agencies.
• Contribute to the development of study protocols, case report forms, and other research documents.
• Maintain effective communication channels among the research team, investigators, and external stakeholders.
• Promote a culture of quality and continuous improvement within the research department.

• Bachelor's degree in a life science, nursing, or related field; Master's degree preferred.
• Minimum of 5 years of experience in clinical research coordination or management.
• Thorough understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Experience in managing clinical research budgets and resources.
• Proven leadership and team management skills.
• Excellent organizational, time management, and problem-solving abilities.
• Strong written and verbal communication skills.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to work effectively in a hybrid environment, balancing remote tasks with on-site responsibilities.
• Experience with various therapeutic areas is a plus.
• Relevant certifications (e.g., ACRP, SoCRA) are advantageous.