Sr Clinical Data Specialist

Fortrea

2+ years

Not Disclosed

Bangalore

10 Nov. 6, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Lead Clinical Data Reviewer
Company: Fortrea
Location: Remote
#LI-Remote

About Fortrea:

Fortrea is a leading global contract research organization (CRO) that specializes in scientific rigor and clinical development. With decades of experience, Fortrea provides pharmaceutical, biotechnology, and medical device clients with a broad range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, we are transforming drug and device development for our partners and patients around the world.

Job Summary:

As a Lead Clinical Data Reviewer at Fortrea, you will be responsible for reviewing and ensuring the quality of clinical trial data, including generating and resolving queries, identifying discrepancies, and reconciling data to support the timely delivery of accurate clinical data. In addition to data review, you may assist in the development of project-specific Data Management Plans (DMPs), data review guidelines, and assist in the technical oversight of small data management projects.

Key Responsibilities:

Data Review & Query Management:
Review clinical trial data to identify errors, missing information, inconsistencies, and implausible data points. Generate, track, and resolve queries to address identified issues.
Data Quality Assurance:
Ensure that all clinical data meets Fortrea’s and the client’s quality and integrity standards. Apply quality control procedures and checks throughout the data review process.
Trend Analysis:
Perform aggregate reviews of clinical data to identify trends related to patient safety, protocol compliance, and data consistency that require further investigation.
Documentation & Compliance:
Review clinical project documents, including protocols, CRFs (or eCRFs), and Data Management Plans, to ensure alignment with data review processes and conventions.
Data Management System Support:
Assist in the development and testing of data management system edits, validation checks, and special listings used to support data review and discrepancy management activities.
Collaboration with Project Teams:
Work closely with Lead Data Managers and Lead Data Reviewers to build project timelines and coordinate data management activities across different disciplines.
Budget & Scope Management:
Monitor and track project budgets, alerting the Lead Data Reviewer of any overages and assisting with the Change Order Log process.
Mentorship & Training:
Mentor and train project staff on project-specific and global standardized data management processes, ensuring the team understands and adheres to best practices.
Audit Support:
Participate in client and internal audits, resolve any findings, and address client comments in a timely and professional manner.
Additional Duties:
Perform other duties as required by management, contributing to the ongoing success of clinical trials and the overall data management process.

Qualifications:

Education & Experience:

Required:
- University or college degree (or equivalent experience).
- Minimum of 4 years of experience in clinical data management, including experience in data review, query management, and working with clinical trial data.
- Familiarity with clinical trial processes, data management systems, and the generation and resolution of queries.

Skills & Competencies:

Clinical Data Knowledge:
Strong understanding of clinical trial data management, including the review of clinical data for completeness, consistency, and accuracy.
Attention to Detail:
Excellent attention to detail, with the ability to identify and resolve discrepancies or errors in clinical trial data.
Problem-Solving:
Ability to generate, resolve, and track queries and provide solutions to data-related issues.
Communication:
Strong communication skills, both written and verbal, with the ability to work collaboratively with cross-functional teams and clients.
Technical Proficiency:
Familiarity with clinical data management tools, systems, and databases. Experience with eCRF, data management systems, and related technologies is a plus.
Project Management:
Ability to manage time effectively, prioritize tasks, and meet deadlines in a fast-paced environment.
Team Collaboration:
Proven ability to work within a team and mentor junior staff members.

Why Fortrea?

Fortrea offers a collaborative and innovative work environment where you will play a vital role in delivering high-quality clinical data that supports the development of life-changing therapies. You will have the opportunity to work alongside a team of passionate professionals who share a commitment to overcoming the barriers in clinical trials and improving patient outcomes.

Fortrea is an Equal Opportunity Employer:
We are dedicated to fostering a diverse and inclusive workforce. Fortrea does not tolerate harassment or discrimination of any kind. We make employment decisions based on business needs and individual qualifications, and we encourage all individuals to apply regardless of their background or identity.

For more information about Fortrea and to apply, please visit www.fortrea.com.

Application Deadline:
Applications will be accepted on a rolling basis until the position is filled.

For more details on how we collect and store your personal data, please review our Privacy Statement.

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Sr Clinical Data Specialist

Job Description

About Fortrea:

Job Summary:

Key Responsibilities:

Qualifications:

Education & Experience:

Skills & Competencies:

Why Fortrea?

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