Centralized Study Specialist I at Fortrea

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Centralized Study Specialist I at Fortrea

Fortrea, a global leader in advancing pharmaceutical, biotechnology, and medical device development, is looking for a Centralized Study Specialist I to join their team in Bangalore, India. Fortrea operates in over 90 countries and focuses on innovation in clinical trials and healthcare delivery, providing a collaborative environment for personal and professional growth. Centralized Study Specialist I at Fortrea

Job Highlights:

PositionCentralized Study Specialist I
CompanyFortrea
Experience2 – 4 Years
Salary6.7 – 9 Lakhs per year
LocationBangalore, India
EducationB.Pharm, M.Pharm, Pharm.D, M.Sc., B.Sc., Life Sciences
Work CultureWork-life balance, Flexibility, Time management, Problem-solving
Centralized Study Specialist I at Fortrea

About Fortrea 🌍

Fortrea is at the forefront of clinical trial innovation, delivering solutions that transform pharmaceutical, biotechnology, and medical device development. With expertise in 20+ therapeutic areas and operations in over 90 countries, Fortrea offers a collaborative and innovative work environment, ensuring creativity and personal growth at every stage of the clinical process. Centralized Study Specialist I at Fortrea

Key Responsibilities

As a Centralized Study Specialist I, you will play a pivotal role in ensuring the successful execution of clinical studies. Below are the main responsibilities:

1. Managing Clinical Systems and Documentation πŸ“‚

  • Manage and maintain clinical study databases such as CTMS, IWRS, and EDC.
  • Organize and support the eTMF (electronic Trial Master File) management.
  • Coordinate with Clinical Research Associates (CRAs) to resolve outstanding issues.
  • Assist with internal/external communications and training compliance for study teams.
    Centralized Study Specialist I at Fortrea

2. Data Review and Monitoring πŸ”

  • Support resolution of data management queries and generate study-specific reports.
  • Perform Lead roles on assigned projects, reviewing Investigator Packages and Informed Consent Forms.
  • Ensure that recruiting materials comply with regulatory requirements.
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3. Site and Vendor Management 🀝

  • Manage site payments, including vendor reconciliation.
  • Assist with contracts and budgets for investigative sites.
  • Help prepare submission packages for regulatory approval.
    Centralized Study Specialist I at Fortrea

4. Quality and Process Improvement πŸ› οΈ

  • Conduct quality checks and escalate issues where necessary.
  • Identify and implement process improvements to enhance study performance.
  • Support the implementation of monitoring tools for clinical studies.

5. Training and Mentorship 🌱

  • Mentor and train junior team members to help them excel.
  • Collaborate with global stakeholders to streamline clinical processes.
    Centralized Study Specialist I at Fortrea

Qualifications πŸ“œ

To excel in this role, you must meet the following criteria:

  • Educational Background: Degree in Life Sciences, Pharmacy, or a related field.
  • Work Experience: Prior experience in clinical trials or data management is preferred.
  • Knowledge of GCP: Familiarity with Good Clinical Practice (GCP) guidelines and regulatory requirements is essential.
    Centralized Study Specialist I at Fortrea

Key Skills and Competencies πŸ’Ό

  • Strong knowledge of clinical systems such as CTMS, IWRS, EDC, and eTMF management.
  • Excellent communication and interpersonal skills to work with global teams.
  • Ability to manage multiple studies and prioritize tasks.
  • Problem-solving and analytical thinking to identify opportunities for improvement.
  • Proficiency in report generation and monitoring metrics.
  • Attention to detail when reviewing documents to ensure regulatory compliance.
    Centralized Study Specialist I at Fortrea
Centralized Study Specialist I at Fortrea
Centralized Study Specialist I at Fortrea

How to Apply

If you are excited about this opportunity and want to grow your career in clinical trials with a company committed to innovation, apply now through Fortrea’s online application system!

Join Fortrea and be part of a company that is transforming healthcare one clinical trial at a time! πŸš€

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