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Job Title: FSP CTC I
Company: Thermo Fisher Scientific
Location: New Delhi, Delhi, India
Job Type: Full-time
Category: Clinical Research
Remote: Fully Remote
Job ID: R-01243974
About Us:
Thermo Fisher Scientific is dedicated to making a positive global impact. Our mission is to enable our customers to make the world healthier, cleaner, and safer. Our Clinical Research team leads the way in bringing cures to market, offering scientific and clinical expertise to develop drugs that address the world’s most pressing health issues. As part of our PPD® clinical research portfolio, we conduct clinical trials in over 100 countries, providing innovative solutions through laboratory, digital, and decentralized services.
Job Description:
As an FSP CTC I, you will provide administrative and technical support to the Project Team. You will ensure audit readiness by reviewing files according to organizational SOPs and department guidelines. Your role includes supporting site activation activities, developing critical paths for site activation, and leveraging local knowledge to review site lists for feasibility activities. You may also train new staff and act as a buddy during onboarding.
A Day in the Life:
- Coordinate and complete assigned trial activities as detailed in the task matrix.
- Perform department, internal, country, and investigator file reviews, documenting findings in appropriate systems.
- Ensure tasks are completed on time, within budget, and to a high standard, proactively communicating risks to project leads.
- Provide system support (e.g., Activate & eTMF) and ensure databases are current.
- Perform administrative tasks such as processing documents for the Client (e)TMF, conducting (e)TMF reviews, distributing communications, and providing reports to team members.
- Analyze and reconcile study metrics and findings reports, assisting with site documentation resolution.
- Coordinate and distribute Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assist with study-specific translation materials and quality control as needed.
- Maintain knowledge of SOPs, client directives, and current regulatory guidelines.
- Support scheduling of client/internal meetings and track local regulatory documents.
- Provide system support and maintain study-specific documentation and systems.
- Transmit documents to the client and centralized IRB/IEC and maintain vendor trackers.
- Support start-up team in regulatory submissions and obtain documents from sites.
- Assist with the preparation of regulatory compliance review packages.
- Ensure site activation activities align with the critical path.
- Complete Site Interest Plans in CTMS and manage communication with sites.
Keys to Success:
Education:
| Requirement | Preferred |
|---|---|
| High/Secondary school diploma or equivalent | Bachelor’s degree |
Experience:
| Requirement |
|---|
| Previous experience in a related role (0 to 1 year) |
Knowledge, Skills, Abilities:
- Ability to work independently and as part of a team.
- Strong organizational skills and attention to detail.
- Ability to handle multiple tasks efficiently.
- Excellent customer focus and flexibility to reprioritize workload.
- Good understanding of applicable Country Regulations, ICH GCP, and SOPs.
- Good English language and grammar skills, and proficiency in the local language as needed.
- Proficient in MS Office and clinical trial database systems.
- Positive attitude, effective communication skills, and good social skills.
- Strong judgment and decision-making skills.
- Good negotiation skills and the ability to lead risk management activities.
- Ability to train new personnel in processes and systems.
Meta Description:
Join Thermo Fisher Scientific as an FSP CTC I for a remote clinical research role in New Delhi, India. Apply now!