Marine Lines Mumbai Maharashtra Project coordinator Jobs – 70 Open Jobs Today

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Clinical Trial Coordinator - (FSP )

Thermo Fisher Scientific -
Mumbai, Maharashtra

Apply Now

Job details

Full-time
13 days ago

Qualifications

Microsoft Powerpoint
Microsoft Word
Project coordination
English
Local language
Microsoft Office
Bachelor's degree
Organisational skills
Clinical trials
Computer skills
Communication skills
Negotiation

Full 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.

Apply Now

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project coordinator jobs in marine lines mumbai maharashtra

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