Clinical Data Analyst II

Posted 7 Days Ago
2 Locations
In-Office or Remote
Entry level
Pharmaceutical
The Role
Supports clinical trial data management by extracting, cleaning, validating, and reconciling data; managing queries; supporting database locks, UAT, CRF tracking, and regulatory documentation. Reviews protocols, CRFs, EDC screens, and data listings to resolve discrepancies and ensure quality and ICH-GCP compliance. Collaborates with study teams and clients, mentors junior analysts, and contributes to process improvements.
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 II

Job Summary

We are looking for a detail-oriented Clinical Data Analyst II to support clinical trial data management activities. The successful candidate will be responsible for managing, analyzing, and validating clinical trial data to support regulatory submissions and clinical research objectives. This role requires strong technical skills, attention to detail, and the ability to work independently while collaborating with cross-functional teams and study start-up support while ensuring compliance with ICH-GCP guidelines and industry standards.

Key Responsibilities

  • Perform clinical data validation: Extract, clean, validate, and reconcile clinical trial data from various sources.
  • Manage data queries and support database lock activities.
  • Review manual and system-generated data listings to identify discrepancies and ensure data quality. Identify and resolve data inconsistencies.
  • Support the preparation and maintenance of Data Management documents and study-related records.
  • Conduct User Acceptance Testing (UAT) for clinical database setups.
  • Review study protocols, CRFs, and EDC screens when required.
  • Track CRFs and support data entry activities as needed.
  • Ensure adherence to SOPs, regulatory requirements, and ICH-GCP guidelines.
  • Collaborate with cross-functional study teams and client stakeholders.
  • Mentor junior data analysts and contribute to process improvement initiatives.

Required Skills

  • Strong analytical and problem-solving abilities.
  • Excellent attention to detail and commitment to quality.
  • Strong verbal and written communication skills.
  • Effective time management and prioritization skills.
  • Ability to collaborate within cross-functional teams.
  • Adaptability and willingness to learn new technologies and processes.

Technical Requirements

  • Experience with Clinical Data Management Systems such as Medidata Rave, Veeva, DataLabs,  ClinBase or others.
  • Understanding of clinical data management processes, including data cleaning and database lock activities.
  • Knowledge of MedDRA and WHODrug coding dictionaries.
  • Basic knowledge of SAS and CDISC standards.
  • Good understanding of ICH-GCP guidelines and clinical research regulations.

Qualifications

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

Skills Required

  • Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related discipline
  • Relevant experience in Clinical Data Management or the Clinical Research industry
  • Experience with clinical data management systems such as Medidata Rave, Veeva, DataLabs, or ClinBase
  • Understanding of clinical data management processes, including data cleaning and database lock activities
  • Knowledge of MedDRA and WHODrug coding dictionaries
  • Basic knowledge of SAS and CDISC standards
  • Good understanding of ICH-GCP guidelines and clinical research regulations
  • Strong analytical and problem-solving abilities
  • Excellent attention to detail and commitment to quality
  • Strong verbal and written communication skills
  • Ability to collaborate within cross-functional teams
  • Effective time management and prioritization skills
  • Adaptability and willingness to learn new technologies and processes

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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