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Clinical Data Analyst

Parexel
Hyderabad, India; Bengaluru, India; Mohali, India; Mumbai, India
Hybrid

About this role

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

About the Role

We are seeking a Clinical Data Analyst (Data Manager, Clinical Operations Analyst) to join our team in a hybrid / on-site capacity. As a Clinical Data Analyst, you will support clinical research activities that advance new treatments for patients. This position plays a key role in study execution, data integrity oversight, regulatory compliance, and clinical data accuracy. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from planning through database lock.

Responsibilities include managing clinical data review workflows, resolving data discrepancies, and ensuring data quality through systematic query management and vendor reconciliation. With diverse teams and continuous learning opportunities, the Clinical Data Analyst can explore career paths and expand skills across clinical data management, regulatory affairs, and clinical operations.

Key Responsibilities

  • Conduct comprehensive clinical data reviews and data cleaning activities to ensure accuracy, completeness, and compliance with study protocols and regulatory requirements
  • Review clinical data listings and identify discrepancies, inconsistencies, and data quality issues requiring resolution
  • Manage query workflows, including query generation, tracking, resolution, and documentation to support timely database closure
  • Perform vendor data reconciliation activities, including local laboratory data review and external data verification to ensure data integrity
  • Execute CRF freeze and lock activities in accordance with study timelines and regulatory standards, coordinating with clinical sites and internal teams
  • Conduct User Acceptance Testing (UAT) for data listings, system screens, and edit checks to validate system functionality and data accuracy
  • Maintain comprehensive study documentation within Veeva Vault and eTMF systems, ensuring proper organization, version control, and regulatory compliance
  • Collaborate with cross-functional stakeholders including clinical monitors, programmers, biostatisticians, and regulatory teams to resolve data issues and support study milestones
  • Demonstrate proficiency with clinical data workbench tools and EDC systems to support efficient data management and analysis

You'll thrive in this role if you bring:

  • Strong expertise in clinical data review, data cleaning, and query management processes

  • Hands-on experience with EDC systems and clinical data analysis tools in a fast-paced environment

  • Proficiency with Veeva Vault, eTMF documentation systems, and clinical data workbench platforms

  • Experience working in clinical research, healthcare, or a regulated environment with attention to regulatory compliance

  • The ability to collaborate across teams and communicate clearly with internal and external stakeholders

  • A patient-focused mindset and exceptional attention to detail in managing complex clinical datasets

  • Comfort working with multiple software systems and a commitment to continuous learning

  • Required Qualifications

  • Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related scientific discipline

  • Minimum 2+ years of experience in Clinical Data Management within a CRO, pharmaceutical, or biotechnology environment

  • Hands-on experience with EDC systems, preferably Medidata RAVE and Oracle Clinical

  • Working knowledge of clinical research regulations, GCP guidelines, and clinical trial processes

  • Knowledge of ICH-GCP, regulatory requirements, and 21 CFR Part 11 compliance

  • Strong communication, organization, and problem-solving skills

  • Preferred Qualifications

  • Experience with data review tools such as J-Review or Spotfire

  • Proficiency with Microsoft Project and advanced PowerPoint presentations

  • Experience in vendor reconciliation and database lock activities

  • Familiarity with clinical trial data management best practices and quality assurance processes

  • Cell and Gene

  • Our Cell and Gene Therapy Center of Excellence (COE) integrates regulatory expertise with a cross-functional team to get treatments to market faster.

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  • General Medicine

  • Our general medicine thought leaders provide innovative development strategies and principled trial design and conduct across the following indications: Cardiovascular, Endocrinology and metabolism, Nephrology and genito-urinary, Respiratory, and Women’s health.

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  • Hematology

  • Our specialists in hematology have long been at the cutting edge of innovations, treating patients participating in clinical trials from first-in-human to post-market studies across the indications of Lymphoma, Acute myelogenous leukemia (AML), Myelodysplastic syndrome (MDS), Multiple myeloma, Benign and malignant disorders.

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  • Infectious Disease and Vaccines

  • Our infectious disease team is built upon the global experience and public health knowledge that drives research within these indications: Hepatitis B, Bacterial indications, Vaccines, preventative, and treatment, Critical care, Long COVID syndrome.

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  • Inflammation and Immunology

  • Our broad knowledge of the underlying mechanisms of diseases, paired with medical expertise and global operations, enable us to support demands in Allergy/immunology, Dermatology, Gastroenterology, Ophthalmology, and Rheumatology.

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  • Neuroscience

  • Enormous advances in the understanding of how the brain works and development of treatment modalities are cause for great hope for millions of people affected by neurological disorders. Our expertise covers all indications across neurology and psychiatry.

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  • Oncology

  • We support treating all major types of cancer, across every phase of development, and the following indications: Benign and malignant hematology, Breast and gynecological cancers, Gastrointestinal cancers, Genitourinary cancers, Lung and head-and-neck cancer, Phase I and rare tumors.

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  • Careers in Neuroscience

  • Neuroscience diseases affect the very core of one’s being and experience. We work diligently to lighten the burden for patients and families alike. Explore opportunities to join our team.

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  • Careers in Cell and Gene

  • Cell and gene therapies (CAGT) have rapidly emerged as among the fastest-growing spaces in all of biopharma R&D, and Parexel was an early entrant into this space.

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  • Our work culture

  • Learn about our culture, perks, learning opportunities, and our corporate responsibility approach. Parexel's compassionate and results-driven work culture prioritizes patient care and employee growth.

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  • Careers in Oncology

  • Our dedicated people, innovative approaches, and culture of caring all work together to ease the journey for patients and investigators.

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  • Careers in Rare Diseases

  • In rare disease, every single patient is precious. Discover where your skills can create a life-changing achievement for every person involved.

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  • Emerging Talent Opportunities

  • Begin your career journey at Parexel with our emerging talent programs or our internships, placements and entry-level clinical roles. Advance science by keeping the patients in mind.

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  • Parexel’s hiring process

  • It’s all about finding the right fit, for you and for us. Our recruiters work with you and our hiring managers to bring together a team and culture where everyone can grow and be successful.

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  • Medical Writing at Parexel

  • Join a global team of 700+ medical writers transforming complex scientific data into clear communications that advance therapies and improve patient care.

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  • Pediatrics

  • Our dedicated team of pediatric experts brings a patient- and family-centered approach to protocol development and study conduct to improve participation, accommodate patients’ needs, and successfully support trials from start to finish.

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  • Rare Diseases

  • Our best-in-class team of rare disease experts are ready to tackle even the most complex

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