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:
| Position | Centralized Study Specialist I |
|---|---|
| Company | Fortrea |
| Experience | 2 – 4 Years |
| Salary | 6.7 – 9 Lakhs per year |
| Location | Bangalore, India |
| Education | B.Pharm, M.Pharm, Pharm.D, M.Sc., B.Sc., Life Sciences |
| Work Culture | Work-life balance, Flexibility, Time management, Problem-solving |
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 📂
- 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 🔍
- 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.
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 🛠️
- 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 📜
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 💼
- 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
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! 🚀