3,906 Clinical jobs in India

TCS is hiring for Clinical Data Management

Job Location Mumbai

Experience Range – 7 to 12 Years

Skillset Required- Knowledge of medical device risk classification

Interested candidates are requested share updated CV with below details on the mail id –

Key Responsibilities

Review and understand the study protocol and the timelines.

Perform data review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate.

Implement study team feedback as required on the data.

Perform external checks to handle manual discrepancies and action the same.

Develop specifications, implementation and testing for the edit checks and listings (DVS)

Perform UAT for database

Develop study specific procedures documents

Ensure effective implementation of standard metric and status reporting on the study

Ensure an error free, quality data with no open queries.

Maintain data management study files and documentation

Attend and provide an update for data management services at cross-functional study team meetings both internally and with the sponsor

Identify out of scope tasks and bring to the attention of the TDM

Assist the TDM in all study set up activities.

Provide all study related reports to the TDM as per the request .

. Perform SAE reconciliation and Vendor data reconciliation

• Assist in the setup, testing, and maintenance of clinical databases (EDC systems).
• Perform data entry, data validation, and discrepancy management.
• Review Case Report Forms (CRFs) and ensure accuracy, completeness, and consistency of clinical trial data.
• Support data cleaning activities, query generation, and resolution with study teams.
• Maintain study documentation as per Standard Operating Procedures (SOPs).
• Collaborate with cross-functional teams such as biostatistics, medical writing, and clinical operations.
• Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
• Participate in internal trainings to develop CDM knowledge and technical skills.

Job Types: Full-time, Permanent, Fresher

Pay: ₹296, ₹523,408.59 per year

Benefits:

• Health insurance
• Paid sick time

Work Location: In person

Job Overview
Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Data Management (DM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; Overview of financial management for data management activities; communications; and milestone deliverables. Perform role of Data Team Lead (DTL). 

Essential Functions
• Gather Study Set up requirements through discussion and communication with relevant stakeholders.
• With Minimal guidance - support, overview of validation of new Device integrations.
• Oversight & Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor.
• Ensure that all the deliverables are of expected quality standards and meet customer expectations.
• With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW).
• Support Training of New joiners.
• Lead internal study meetings and internal/ sponsor audits and participate in Study Kick off meetings and other sponsor meetings.
• Tracks and manages the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended as required.
• With Guidance manage & oversight the implementation of new technology / database revisions.
• Work closely with the programming team for process innovation and automation.
• Be compliant to trainings and eSOP reading.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
• Communication with Line Manager, and other team members across functions should be collaborative.
• Perform other duties as directed by Line Manager.

Qualifications
• Bachelor's Degree Bachelor Pharmacy or equivalent Pref
• 3 -4 years direct Data Management experience, including a minimum of 1 year as a CDM project lead. Pref
• English Fluency Spoken and English Advanced
• Advanced computer applications like Microsoft excel, word, Inbox etc Advanced
• Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process Advanced

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

Company Description

QREC Clinical Research LLP is a Contract Research Organisation with offices in Jaipur (India), Hyderabad (India), and Dubai (UAE). The company offers comprehensive services to the healthcare industry, doctors, and researchers in clinical trials (Phase 3 & 4), REAL WORLD studies, observational studies, PMS, KAP surveys, investigator-initiated studies, medical writing, clinical data management, statistical analysis, and medico marketing globally. QREC has successfully completed numerous projects, including 450+ brand plans, 162+ REAL World studies, and 810+ statistical analysis projects, supported by a database of 45,000+ doctors and 8,10,000+ patients.

Role Description

This is a full-time on-site role for a Clinical Study Coordinator, located in Jaipur. The Clinical Study Coordinator will be responsible for daily tasks such as coordinating and managing clinical trials, obtaining informed consent from participants, ensuring adherence to protocols, and conducting research. The role includes responsibilities such as data collection, maintaining study documentation, overseeing regulatory compliance, and collaborating with investigators and clinical staff.

Qualifications

• Experience in Informed Consent and Protocol adherence
• Clinical Research Experience and Clinical Trials management skills
• Strong research and data collection abilities
• Excellent organizational and documentation skills
• Knowledge of regulatory compliance and guidelines
• Effective communication and collaboration skills
• Bachelor's degree in Clinical Research, Life Sciences, or a related field
• Experience in the healthcare industry is a plus

Date: 22 Sept 2025

Location:

IN

Custom Field 1: Discovery Services

Job Description
Job Title: Clinical Study Manager

About Syngene : Syngene ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit
Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company's integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene' s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Role Accountabilities

• Manage and co-ordinate efforts of Clinical Trial Management department and cross-functional project teams to support project milestone achievement and to manage study issues and obstacles
• Develop Project Management Plan
• Coordinate with cross-functional departments/Sponsor/Vendor for development of study management plans
• Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to
• Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures during the project tenure
• Collect information on team performance against contract, customer expectations and project baselines
• Lead problem solving and undertake resolution efforts for management of risks, contingencies and issues
• Identify quality issues within the study through regular review of the clinical team communications including site communications, monitoring visit reports, data flow information and quality assurance audit findings, to implement appropriate corrective action plans, escalate findings and action plans to appropriate parties.
• Providing ongoing training and support to the clinical team.
• Ensure high performance and efficiency of the clinical team through co-monitoring/accompanied site visits
• Mentor and provide oversight to the Clinical Research Associate team and scheduling accompanied visits with Clinical Research Associate for pre-study, initiation, monitoring and close-out visits as part of their on-site assessment.
• Prepare and present project information at internal and external meetings.
• Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas.
• Ensure data quality, compliance with protocol, relevant SOPs and regulations at study sites for which Senior Clinical Research Associates/ Clinical Research Associates is responsible (if applicable)
• Provide/ facilitate training, development, performance and retention of assigned clinical team.
• Meet with Senior Clinical Research Associates, Clinical Research Associates, Senior Project Associates and Project Associates on a regular basis to monitor workload and performance
• To review and validate timesheet of Senior Clinical Research Associates/ Clinical Research Associates and provide input to reporting managers of their project team members' performance and deficiencies in timesheet entries relative to project tasks
• Provide input for the development of proposals for new work and manage project budgets.
• Participate in performing site feasibility for awarded studies
• Develop and review of departmental Standard Operating Procedures and working practices
• Co-ordination with Quality Assurance (QA) team for the closure of audit findings both in-house and on-site audits
• As reporting manager (if assigned), manage the team in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning and directing work; goal setting, appraising performance and guiding professional development; training, rewarding and disciplining employees; addressing employee relations issues and resolving problems

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Accountabilities as a Syngene Leader (only for Leadership Hires)

• Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities.
• Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.
• Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.

Experience: 15 to 20 years

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Education MBBS/MD/MS

Literature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports).

Review of Literature Strategy Design and interpretation of various types of studies in medicine, levels of evidence, study power for the purpose of safety analyses.

Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER (e. g 5.2.4, 6.2, 9.2, 15 & 16).

Authoring of RMP updates & implementation plans.

Review of various types of listings for Signal Detection Understanding of signal journey and knowledge of signal management systems and process requirements.

DSR - Complete authoring, Single case analysis & MAH comments, Drafting Overall Conclusion and Review - Must have skillset ICSR Aggregate Reporting Signal Management

Exp.- 4-12yrs

Contact Person - Hariharan

Email -

Job Title: Clinical Trial Manager

Onsite - Hyderabad

Company Overview: We eteraflex connects a fast-growing global CRO specializing in oncology, rare diseases, and immunotherapies. Our mission is to accelerate access to innovative treatments by combining regulatory precision with deep site engagement, particularly in complex government-led research environments across India.

Position Summary: We are seeking an experienced Clinical Trial Manager (CTM) to lead the execution of Phase I, II and III oncology studies at key national institutions in India. This role is pivotal in driving site activation, regulatory compliance, and clinical delivery in alignment with global sponsor expectations.

Key Responsibilities:

• Lead clinical operations and site-level engagement for assigned Phase’s studies in India
• Manage relationships with Principal Investigators (PIs), CRCs, and Institutional stakeholders at government hospitals
• Oversee timely and compliant PSSV, site initiation visits (SIV), patient recruitment, and data collection
• Ensure study milestones are met, including First Patient First Visit (FPFV) and clean database targets
• Collaborate with sponsor teams, regulatory consultants, and third-party vendors to streamline dossier submissions and audit readiness
• Coordinate regulatory submissions and ethics committee (EC) approvals;
  ensure alignment with CDSCO, ICMR, and local EC timelines
• Conduct ongoing risk assessment and drive mitigation strategies across sites
• Provide oversight to field CRAs and monitor site compliance
• Contribute to internal SOP development and quality initiatives

Key Qualifications:

• Bachelor’s degree in life sciences or related field;
  advanced degree preferred
• Minimum 6-8 years of clinical research experience with at least 3 years in an independent CTM role
• Demonstrated experience in oncology or immunotherapy trials, preferably with exposure to AIIMS or government research centers
• Strong working knowledge of GCP, ICH, and CDSCO guidelines
• Proven track record managing multi-site studies and remote monitoring teams
• Excellent interpersonal, communication, and problem-solving skills
• Proficiency in CTMS, EDC, and eTMF systems is a plus

Job description:

Clinical Project Manager

1. Proactively manages clinical trials from start-up to closure with a focus on trial timelines, quality, budget, and vendor oversight.

2. Leads selection of CRO and vendors including identification of potential vendors, RFP process, qualification of vendors where required and contract negotiation.

3. Supports preparation of regulatory dossier by providing documents and required information

4. Leads the study start-up process, including, but not limited to, preparation of the trial kick-off meeting, study documents, plans and manuals, set-up of the trial master file (TMF), and site feasibility process (where applicable).

5. Collaborates with the Clinical Trial Supply Management function to ensure an effective procurement and supply strategy for study medication, with no stockouts during trial and low overage at study end.

6. Oversees CRO and vendors during the trial to ensure compliance with project requirements, internal processes, timelines, budget, ICH GCP, and local and international laws.

7. Monitors the quality of vendor deliverables, addresses quality issues with the appropriate team members and identifies opportunities to improve training, execution and quality control.

8. Oversees monitoring of clinical trials, ensuring high-quality trial execution at sites, identification of deviations and implementation of mitigation strategies as required.

9. Ensures study is at all times inspection ready.

10. Provides efficient updates on trial progress to Head of Clinical Operations and Senior Management.

11. Ensures trials are registered in trial registries (as applicable) and accuracy of trial information and that updates and final reporting are submitted on time.

12. Ensures timely shipment and tracking of lab samples to ensure no loss of samples due to lack of operational oversight and availability for timely analysis for study reporting.

13. Ensures risk management plans and contingency plans are available for assigned trials and escalates key study risks to the attention of the Head of Clinical Operations/Senior Management. 14. Reviews and approves vendor invoices in collaboration with the Development Finance Specialist/Finance department personnel to ensure vendor payments occur in a timely manner

15. Supports vendor and site audits, follows up on audit findings to ensure appropriate responses and CAPAs implemented by vendors and sites.

16. Ensures all project-level study documentation is filed in the TMF in accordance with applicable SOPs, guidance documents and regulatory requirements and provides oversight to the CRO team regarding TMF filing, maintenance and archival procedures.

17. Supports preparation of responses to queries from Regulatory, Marketing or any other molecule related queries.

18. Ensures at study end that eTMF is completed and archived, budget reconciled, lab samples and IMP samples retained or discarded as per internal decisions.

19. Supports SOP development and review, participates in internal process improvement activities and other activities as needed.