8,050 Clinical Research jobs in India

• Design and develop clinical trial protocols in alignment with regulatory requirements and scientific objectives.
• Oversee the conduct of clinical trials, ensuring data integrity, patient safety, and protocol compliance.
• Select and qualify clinical trial sites and investigators.
• Monitor trial progress and manage timelines, budgets, and resources effectively.
• Analyze clinical trial data and interpret results to support regulatory submissions and product development.
• Prepare clinical study reports, manuscripts, and presentations for scientific and regulatory audiences.
• Collaborate with cross-functional teams, including R&D, regulatory affairs, and marketing.
• Stay current with scientific literature, emerging technologies, and regulatory changes in the pharmaceutical industry.
• Manage vendor relationships and ensure the quality of outsourced services.
• Contribute to the strategic planning of clinical development programs.

• PhD or Master's degree in Life Sciences, Pharmacy, Medicine, or a related field.
• 5-8 years of experience in clinical research within the pharmaceutical or biotechnology industry.
• In-depth knowledge of Good Clinical Practice (GCP), ICH guidelines, and regulatory affairs.
• Proven experience in designing and managing clinical trials across different phases.
• Strong understanding of statistical principles for clinical data analysis.
• Excellent scientific writing and presentation skills.
• Ability to work effectively in a cross-functional team environment.
• Strong analytical and problem-solving abilities.
• Proficiency in relevant software and data management systems.
• Adaptability to a hybrid work environment and strong organizational skills.

• Design and develop clinical trial protocols in alignment with scientific objectives and regulatory requirements.
• Oversee the execution of clinical trials, ensuring adherence to GCP and other relevant guidelines.
• Manage relationships with clinical sites, investigators, and study coordinators.
• Monitor study progress, data quality, and patient safety throughout the trial lifecycle.
• Analyze clinical trial data, interpret results, and contribute to the preparation of study reports.
• Collaborate with biostatisticians and data management teams to ensure data integrity.
• Prepare regulatory submissions, including Investigational New Drug (IND) applications and New Drug Applications (NDA).
• Contribute to the development of scientific publications and presentations.
• Stay abreast of the latest scientific advancements and regulatory changes in the pharmaceutical industry.
• Provide scientific and clinical expertise to internal teams and external partners.

• Ph.D. or M.D. in a relevant scientific discipline (e.g., Pharmacology, Medicine, Biology).
• Minimum of 5 years of experience in clinical research within the pharmaceutical or biotechnology industry.
• Proven track record in designing and executing Phase I, II, III, or IV clinical trials.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements (e.g., FDA, EMA, CDSCO).
• Strong understanding of drug development processes and biostatistics.
• Excellent scientific writing, presentation, and communication skills.
• Demonstrated ability to analyze complex scientific data and draw sound conclusions.
• Experience with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to work collaboratively in a team environment and manage multiple projects effectively.
• Strong problem-solving skills and attention to detail.

TCS is Hiring -Clinical Safety Scientist

location - Mumbai, Noida, Bengaluru

Experience Range - 5 to 10

Preferred Educational Qualification for the role - Any life science Graduate

Job Description

Literature Review

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

Provide MAH comments for selected literature

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.

Thesaurus used for indexing medical scientific literature, relevant for literature search strategy tailoring (both ad-hoc and systematic).

Review and interpretation of current expert therapeutic guidelines for the purpose of various safety analyses.

Review of outputs triaged by the safety scientist for scientific accuracy taking into consideration all of the above criteria

Aggregate Reports:

Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER.

Authoring of RMP updates & implementation plans.

Provides methodology (in collaboration with Roche clinical safety) for data presentation and assessment in the pertinent safety sections of the aggregate report (use outside the indication scope, use in special population, medication errors, characterization of risks etc.)

Asses the new information received on important safety concerns for the medicinal product.

Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy

Signal Management

Review of various types of listings for Signal Detection

Understanding of signal journey and knowledge of signal management systems and process requirements.

Perform Signal validation with a brief summary.

DSR - Complete authoring, Single case analysis & MAH comments, Drafting Overall Conclusion and Review

Tailoring strategy and methodology for signal assessment

Overall assessment of the signal based on the presented data and respective recommendation for action

Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy

• Lead the scientific design and development of clinical trial protocols, ensuring they meet regulatory requirements and scientific objectives.
• Oversee the execution of clinical studies, working closely with clinical operations teams, investigators, and CROs.
• Analyze and interpret complex clinical trial data, including efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) data.
• Prepare comprehensive clinical study reports (CSRs) and contribute to regulatory submissions (e.g., IND, NDA, BLA).
• Collaborate with cross-functional teams, including R&D, medical affairs, biostatistics, and regulatory affairs.
• Provide scientific and clinical expertise to internal and external stakeholders.
• Stay abreast of the latest scientific advancements, competitive landscape, and regulatory guidelines in relevant therapeutic areas.
• Mentor junior scientists and contribute to the development of scientific strategies.
• Evaluate new scientific opportunities and contribute to portfolio planning.
• Represent the company at scientific conferences and in interactions with regulatory agencies.

• PhD or equivalent doctoral degree in a life science, biomedical engineering, pharmacology, or a related field.
• Minimum of 10 years of experience in clinical research within the pharmaceutical or biotechnology industry, with a strong focus on study design and data interpretation.
• Proven track record of successfully leading clinical trials from concept to completion.
• In-depth knowledge of drug development processes, clinical trial methodology, and regulatory requirements (e.g., FDA, EMA).
• Expertise in statistical analysis and interpretation of clinical data.
• Excellent scientific writing and verbal communication skills.
• Demonstrated ability to collaborate effectively in a remote, cross-functional team environment.
• Strong analytical and problem-solving skills.
• Experience in relevant therapeutic areas (e.g., oncology, immunology, CNS) is highly desirable.

• Lead the design and development of innovative clinical trial protocols.
• Oversee the execution of clinical studies, ensuring adherence to protocols and regulatory guidelines.
• Analyze and interpret complex clinical data, generating meaningful insights.
• Prepare scientific reports, publications, and regulatory submission documents.
• Collaborate with cross-functional teams, including medical affairs, regulatory affairs, and biostatistics.
• Manage relationships with investigators, study sites, and key opinion leaders.
• Provide scientific guidance and strategic input throughout the drug development process.
• Stay abreast of the latest scientific literature, clinical trends, and regulatory requirements.
• Contribute to the development of disease area strategies and pipeline prioritization.

• Ph.D. or M.D. in a relevant life sciences discipline (e.g., Pharmacology, Biology, Medicine).
• Minimum of 7 years of experience in clinical research and drug development within the pharmaceutical industry.
• Extensive experience in designing, executing, and analyzing Phase I-IV clinical trials.
• In-depth knowledge of Good Clinical Practice (GCP) and relevant regulatory guidelines (FDA, EMA).
• Proven experience in a specific therapeutic area (e.g., oncology, cardiology, neurology).
• Strong scientific writing and presentation skills.
• Excellent analytical and problem-solving abilities.
• Demonstrated ability to work effectively in a remote, collaborative team environment.
• Strong project management and organizational skills.