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Sr Clinical Data Specialist

3-5 years
Preferred by Comapny
12 Nov. 25, 2024
Job Description
Job Type: Full Time 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: Clinical Data Manager
Location: San José, Costa Rica
Time Type: Full-Time

About Fortrea

Fortrea is a leading global Contract Research Organization (CRO) dedicated to advancing clinical development, patient access, and technology solutions for pharmaceutical, biotechnology, and medical device companies. With operations in over 90 countries, we are redefining the drug and device development process to deliver life-changing therapies efficiently and effectively to patients worldwide.

Position Overview

We are seeking a Clinical Data Manager to join our San José, Costa Rica team. This role involves contributing to the data management process for clinical trials, ensuring data quality and integrity while adhering to project timelines. You will work collaboratively with internal teams, sponsors, and external vendors, managing clinical trial data and supporting the delivery of accurate and timely results.

Key Responsibilities

  • Review clinical trial data in alignment with Global Data Management Plans and SOPs.
  • Identify and resolve data discrepancies through query generation and resolution.
  • Perform aggregate reviews to spot trends in patient safety, compliance, and data consistency.
  • Apply quality control procedures to maintain data standards.
  • Assist in the development of Data Management Plans (DMP) and related guidelines.
  • Design, test, and validate database and data review systems to meet project specifications.
  • Collaborate with external vendors on data transfer and protocol requirements.
  • Ensure external vendor data adheres to protocol-specified parameters and is integrated correctly.
  • Support the development and QC of edit checks, ensuring proper functionality.
  • Maintain project timelines and deliverables while providing updates to stakeholders.

Qualifications

Minimum Required:

  • Bachelor’s degree in Life Sciences, Health Sciences, or a related field.
  • 1-3 years of experience in Clinical Data Management or working with Clinical Trial protocols.
  • Strong knowledge of clinical trial processes, clinical operations, and data management systems.
  • Proficient in time management and adhering to project productivity metrics.
  • Strong organizational, communication, and teamwork skills.
  • Familiarity with medical terminology and a scientific background (preferred).

Preferred:

  • Two or more years of experience with Electronic Data Capture systems.
  • Knowledge of Fortrea’s operations and structure.

What We Offer

Joining Fortrea means becoming part of a global team focused on transforming clinical research. We provide a collaborative work environment that supports personal growth and offers the chance to make a meaningful global impact.

Benefits Include:

  • Competitive salary and benefits package.
  • Opportunities for professional development and career growth.
  • Inclusive and diverse work culture.

Why Choose Fortrea?

Fortrea is driven by a mission to break barriers in clinical trials and accelerate the development of life-saving therapies. As part of our team, you’ll play a crucial role in delivering innovative solutions that change lives.

How to Apply

To join our dynamic team, visit www.fortrea.com.

Contact:
For questions or further information, please refer to job requisition ID: 2445158.

Fortrea is proud to be an Equal Opportunity Employer. We are committed to fostering an inclusive workforce free from harassment or discrimination. For details about our data collection practices, please refer to our Privacy Statement.