Clinical Data Analyst III

Posted Yesterday
Be an Early Applicant
2 Locations
In-Office or Remote
Mid level
Pharmaceutical
The Role
Leads clinical data validation, cleaning, reconciliation, query management, database quality control, UAT, and database lock activities across clinical studies. Reviews protocols, EDC configurations, CRFs, vendor data, and data management documentation while ensuring ICH-GCP and regulatory compliance. Identifies risks, supports study start-up and planning, analyzes operational metrics, mentors analysts, serves as a subject matter expert, and provides backup support to the Data Management Lead.
Summary Generated by Built In

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Clinical Data Analyst III

Job Summary

We are seeking an experienced Clinical Data Analyst III (CDA III) to independently lead clinical data validation and data management activities across clinical studies. The role requires expertise in clinical data review, reconciliation, database quality control, risk identification, study start-up support, and cross-functional collaboration. The successful candidate will act as a Subject Matter Expert (SME), mentor junior team members, and contribute to process improvements while ensuring compliance with ICH-GCP guidelines and regulatory requirements.

Key Responsibilities

  • Independently perform and lead clinical data validation, cleaning, review, and reconciliation activities throughout study conduct and database lock.
  • Manage data queries and conduct manual and SAS-generated listing reviews.
  • Perform reconciliation of external vendor data and ensure data integrity across systems.
  • Identify project risks, highlight delivery concerns, and support mitigation planning.
  • Support the preparation and maintenance of Data Management documentation and Trial Master File records.
  • Lead User Acceptance Testing (UAT) activities for clinical database setups.
  • Review study protocols, EDC screens, and database configurations.
  • Provide input into data management timelines and coordinate operational activities during study start-up.
  • Track and review CRFs and support data entry activities as required.
  • Perform quality control reviews and ensure compliance with SOPs, ICH-GCP guidelines, and regulatory requirements.
  • Act as a mentor and provide on-the-job training to Clinical Data Analysts.
  • Serve as a Subject Matter Expert (SME) for data management tools, systems, and processes.
  • Support continuous improvement initiatives and implementation of project-specific tools and efficiencies.
  • Provide operational metric analysis and support scope change assessments and resource planning.
  • Act as backup to the Data Management Lead when required.

Required Skills

  • Strong leadership and collaboration skills with the ability to coordinate global and virtual teams.
  • Ability to independently interact with sponsors and stakeholders regarding data issues and study requirements.
  • Strong negotiation, influencing, and stakeholder management skills.
  • Advanced problem-solving and root cause analysis capabilities.
  • Exceptional attention to detail and commitment to first-time quality.
  • Strong organizational, prioritization, and time-management skills.
  • Excellent written and verbal communication skills.
  • Effective presentation and knowledge-sharing abilities.
  • Adaptability and ability to work in dynamic, fast-paced environments.
  • Strong mentoring and coaching skills.

Technical Requirements

  • Strong experience with Clinical Data Management Systems such as Medidata Rave, Oracle InForm, Veeva, DataLabs, or ClinBase.
  • Advanced understanding of clinical data management processes, including data cleaning, reconciliation, and database lock activities.
  • Expertise in database setup activities and data validation specifications.
  • Knowledge of MedDRA and WHODrug coding dictionaries.
  • Understanding of CDISC standards.
  • Basic knowledge of SAS and programmed listings.
  • Strong knowledge of ICH-GCP guidelines, clinical research regulations, and industry best practices.
  • Experience leading virtual data management teams across global studies.

Qualifications

  • Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related healthcare discipline.
  • Relevant experience in Clinical Data Management within the clinical research or CRO industry.

Demonstrated experience leading data management activities across clinical

Skills Required

  • Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related healthcare discipline
  • Relevant experience in Clinical Data Management within the clinical research or CRO industry
  • Experience with clinical data management systems such as Medidata Rave, Oracle InForm, Veeva, DataLabs, or ClinBase
  • Advanced understanding of clinical data management processes, including data cleaning, reconciliation, and database lock activities
  • Expertise in database setup activities and data validation specifications
  • Knowledge of MedDRA and WHODrug coding dictionaries
  • Understanding of CDISC standards
  • Basic knowledge of SAS and programmed listings
  • Strong knowledge of ICH-GCP guidelines, clinical research regulations, and industry best practices
  • Experience leading virtual data management teams across global studies
  • Leadership, collaboration, stakeholder management, negotiation, and influencing skills
  • Advanced problem-solving and root cause analysis capabilities
  • Strong mentoring and coaching skills

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

Parexel Insights

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The Company
HQ: Raleigh, NC
20,524 Employees

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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