Centralized Study Specialist I
Centralized Study Specialist I
Fortrea
Job description
Looking to build a career in centralized clinical study coordination? Explore this Centralized Study Specialist I role at Fortrea in Bangalore.
Company Description
Fortrea is a global clinical research company focused on advancing life saving therapies for patients. The company believes in turning the impossible into possible through teamwork and shared commitment. Fortrea supports trials and drug development through strong scientific expertise and reliable service. With a culture built on collaboration the company continues to break barriers in clinical research.
Job Summary
This role supports study management activities across assigned clinical trial projects. As a Centralized Study Specialist you will manage study documents, clinical systems and reporting tasks to keep studies on track. You will coordinate closely with Clinical Research Associates and study teams to resolve issues. The role also involves supporting Trial Master File management and helping maintain project health metrics.
Key Responsibilities
Follow departmental SOPs and work instructions in tasks.
Complete day to day tasks while maintaining quality and productivity.
Execute timely monitoring and reporting plans, including specialized requests.
Track and report project metrics within required timelines.
Identify process improvement opportunities and support their implementation.
Mentor and train other team members as needed.
Manage clinical systems, including CTMS, IWRS and EDC platforms.
Support eTMF management and study document organization.
Track and follow up with CRAs to resolve issues.
Support the preparation of study specific reports.
Manage internal and external communications for assigned studies.
Support training compliance and study payment processes for sites and vendors.
Prepare CRA prep packs. Coordinate before site visits.
Support Trial Master File documentation and TMF quality control activities.
Update milestones across MS Project, CTMS and related tools.
Escalate risks to project timelines in a timely manner.
Support project plans and coordinate feedback between study teams and clients.
Support vendor management tasks, including invoice tracking and PO requests.
Handle documentation, support system related tracking, as needed.
Educational Qualification
University or college degree, in life sciences or a certification in an allied health profession, such as nursing or lab technology.
Candidates without a life sciences background may also be considered, based on experience.
Skills Required
5 to 8 years of clinical research experience within pharma, CRO or healthcare settings.
Working knowledge of ICH, regulatory and IRB or IEC guidelines.
Basic understanding of the clinical trial process.
Strong organizational and time management skills.
Good computer literacy, including MS Office tools like Word, Excel and PowerPoint.
Strong attention to detail and consistent work quality.
Good communication skills and the ability to work well with others.
Willingness to work in shifts if business needs require it.
Salary Structure
The average salary for a Centralized Study Specialist I at Fortrea in India ranges from ₹4 Lakhs to ₹9 lakhs per year.
Career Development
This role offers hands on exposure, to clinical study operations within a respected research organization. Fortrea also supports long term growth through mentorship opportunities and a collaborative team culture built around shared success.
How to Apply
Visit our job portal and search for the Centralized Study Specialist I role - Fortrea.
Click on the job posting to read all the details, about the job.
Fill in your details. Upload your updated resume.
Send your application.
Education
Postgraduate Degree (Master's/PhD)
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
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