Clinical Trial Coordinator - (FSP )

ThermoFisher Scientific; Mumbai; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Clinical Trial Coordinator to join our global team in Mumbai. You will provide administrative and technical support for project teams, aiding in site activation and development of critical paths for rapid activations.

You may review study documents and assist in timely risk assessment and regulatory readiness. You will collaborate with study managers, CROs, and regulatory functions to ensure accurate documentation across global trials and support training

Qualifications

• Bachelor's degree preferred.
• 2+ years' experience in global clinical trial support as a CTC / Project Coordinator.
• Experience in Phase 2 and 3 studies and global/international studies is advantageous.
• Experience across multiple therapeutic areas (including oncology) is advantageous.
• Have experience in Veeva Vault, Hands on experience in eTMF life cycle.

Responsibilities

• Provide support for critical day-to-day clinical study activities under supervision.
• Collaborate with CROs and study teams to support clinical study activities.
• Review essential documents packets and study plans.
• Support risk-based monitoring and regulatory inspection readiness.
• Attend key team meetings and record minutes for selected studies.
• Support study close-out activities and financial reconciliation.

Skills

Teamwork

Attention to detail

Regulatory knowledge

Project coordination

Communication

Education

Bachelor's degree

Tools

Veeva Vault

eTMF lifecycle

MS Office

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Trial Coordinator - Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you'll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coord, you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing CRG personnel, you may utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. Additionally, you may act as a buddy during the onboarding phase and provide training to new staff as needed.

What You'll Do:

• Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the Functional Service Provider (FSP) Manager and in collaboration with Client Management
• Collaborate with Clinical Operations/Study Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
• Review of study documentation, including essential document packets, study plans, informed consent forms, etc.
• Supporting/oversight of risk-based monitoring.
• Attendance of key team meetings as required, including Minutes for selected studies
• Supporting regulatory inspection readiness (e.g. SOP Lists, storyboard collation.)
• Support clinical trial systems (e.g. CTMS/TMF associated activities for selected studies
• Supporting vendor contract administration as required.
• Support study close-out activities, e.g. financial reconciliation
• Supporting additional ad-hoc activities as needed, as agreed with Manager(s).

Education and Experience Requirements:

• Bachelor's degree preferred.
• 2+ years' experience in global clinical trial support as a CTC / CTC / Project Coordinator
• Experience in Phase 2 and 3 studies and global/international studies is advantageous.
• Experience working across multiple therapeutic areas (including oncology) is advantageous
• Have experience in Veeva Vault, Hands on experience in eTMF life cycle

Knowledge, Skills and Abilities:

• Ability to work in a team or independently as required
• Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Flexibility to reprioritize workload to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
• Good English language and grammar skills and proficient local language skills as needed
• Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
• Ability to successfully complete the organizations clinical training program
• Self-motivated, positive attitude and good interpersonal skills
• Effective oral and written communication skills
• Good interpersonal skills
• Essential judgment and decision-making skills
• Capable of accurately following project work instructions
• Good negotiation skills
• Independent thinker
• Ability to manage risk and perform risk escalation appropriately

Working Conditions and Environment:

• Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential Occasional travel required.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.