Thermo Fisher FSP CTC II Jobs | Clinical Trial Coordinator II

Thermo Fisher Scientific Hiring – FSP CTC II | Clinical Trial Coordinator II

Thermo Fisher Scientific is hiring for FSP CTC II within its Clinical Research Services / PPD clinical research portfolio in Mumbai.
The role supports clinical trial teams with site activation, feasibility, document management, regulatory tracking, and trial coordination activities.
Candidates with a Bachelor’s degree preferred and at least 2 years of comparable Clinical Trial Coordinator (CTC) experience can apply.
Experience with Veeva eTMF, CTMS, global clinical trials, and coordination with local/global teams is specifically required.

Thermo Fisher Scientific – Clinical Research Department

FSP CTC II

Job ID: R-01367751
Job Type: Full-time
Location: Mumbai, Maharashtra, India
Work Mode: Fully Remote
Category: Clinical Research
Work Schedule: Standard (Monday–Friday)

Thermo Fisher Scientific – FSP CTC II Role

Clinical Trial Coordination

The FSP CTC II role provides administrative and technical support to clinical trial project teams and contributes to site activation, feasibility, documentation, tracking, and project delivery activities.

Thermo Fisher Scientific – Key Responsibilities

FSP CTC II – Clinical Trial Activities

• Coordinate, oversee, and complete assigned trial activities according to the applicable task matrix.
• Perform department, internal, country, and investigator file reviews and document findings in the relevant systems.
• Ensure assigned tasks are completed on time, within budget, and to the required quality standards.
• Communicate project risks proactively to project leads and the line manager.
• Process documents sent to the client eTMF and perform eTMF reviews.
• Support mass mailings, communications, and distribution of documents and reports to internal teams.
• Review and track local regulatory documents.
• Analyze and reconcile study metrics and findings reports.
• Support clarification and resolution of site documentation findings.
• Maintain vendor trackers.
• Assist with coordination, compilation, and distribution of Investigator Site File and Pharmacy binder materials and non-clinical study supplies.
• Support study-specific translation materials and translation quality control.
• Provide technical and administrative support in collaboration with internal departments and team members.
• Maintain knowledge of SOPs, client directives, regulatory guidelines, and applicable work practices.
• Ensure trial status information is accurately maintained in relevant databases.
• Maintain relationships with client local affiliates where applicable.
• Support Strategic Collaboration site inclusion in the process.
• Conduct onsite feasibility visits where applicable for Asia-Pacific activities.
• Train new personnel in processes and systems.
• Support study-specific documentation, systems, tools, trackers, training requirements, and system access management.
• Ensure the eTMF remains up to date according to scheduled file reviews.
• Provide system support for platforms such as Activate and eTMF where applicable.
• Support risk-based monitoring activities.
• Transmit documents to clients and centralized IRB/IEC where required.
• Attend Kick-Off Meetings and take meeting notes when required.
• Support scheduling and organization of client and internal meetings.
• Support site start-up activities and alignment with the site activation critical path.
• Assist with regulatory compliance review packages.
• Support regulatory submissions during study start-up where applicable.
• Obtain site-selection documents directly from sites when required.
• Develop and maintain site lists using internal and external sources.
• Maintain investigator and site staff contact information in company systems.
• Complete Site Interest Plans in CTMS and document site communications and follow-ups.
• Review survey data for completeness, logic, and relevance.
• Collaborate with clinical teams to meet project deadlines and resolve site issues.
• Maintain efficient plans for site contact and follow-up and escalate concerns where needed.
• Support local knowledge of site capacity and experience and contribute to site tiering.
• Conduct physician and site personnel interviews to support trial optimization projects.
• Liaise with Global Investigator Services to resolve investigator queries.
• Contribute to global strategic feasibility processes and best practices.

Thermo Fisher Scientific – Education & Experience

FSP CTC II – Eligibility & Qualifications

Bachelor’s Degree Preferred

Candidates should also have:

At least 2 Years of Comparable Clinical Trial Coordinator Experience

The source specifically requires previous CTC experience providing the knowledge, skills, and abilities needed to perform the role.

Thermo Fisher Scientific – Mandatory Experience

FSP CTC II – Required Systems Experience

• Veeva eTMF experience
• CTMS experience
• Experience working on global clinical trials
• Experience coordinating with local and global team members

Preferred Experience

Vendor Management experience is preferred.

Thermo Fisher Scientific – Required Skills

FSP CTC II – Professional Skills

• Ability to work independently or as part of a team.
• Strong organizational skills and attention to detail.
• Ability to manage multiple tasks efficiently.
• Strong project-data and systems analysis skills.
• Strong customer focus.
• Flexibility and adaptability when project priorities change.
• Knowledge of applicable country regulations.
• Knowledge of ICH Good Clinical Practices (GCP).
• Understanding of organizational and client SOPs and work practices.
• Excellent English language and grammar skills.
• Local language proficiency as required.
• Good presentation skills.
• Strong MS Office skills, including Word, Excel, and PowerPoint.
• Ability to learn and use clinical trial database systems.
• Effective oral and written communication skills.
• Strong interpersonal and negotiation skills.
• Basic medical terminology and therapeutic area knowledge.
• Basic organizational and planning skills.
• Basic knowledge of local health systems.
• Ability to manage risks and escalate issues appropriately.
• Ability to work effectively in a matrix environment.
• Relationship-building skills and independent thinking.

Thermo Fisher Scientific – Clinical Research Knowledge

FSP CTC II – Regulatory & Clinical Skills

The role requires the ability to maintain working knowledge of:

GCP | Applicable SOPs | Country Regulations | Clinical Trial Processes | Medical Terminology | Site Activation | Feasibility | Regulatory Documentation

Thermo Fisher Scientific – Working Conditions

FSP CTC II – Work Environment

The position may involve work in:

• Office environment
• Laboratory environment
• Clinical environment
• Home-office environment

The role may also require occasional drives to site locations and occasional travel.

Job Location

Thermo Fisher Scientific – Mumbai

Mumbai, Maharashtra, India

Work Mode: Fully Remote

How to Apply

Interested and eligible candidates can apply through the official Thermo Fisher Scientific careers portal.

Official Job: Apply for FSP CTC II – Thermo Fisher Scientific

Job Summary