Clinical Trial Associate

Concept Medical; Surat; On-site; INR 350,000 - 550,000; Full time

Job summary

Concept Medical is seeking an Associate Clinical Trial to provide administrative support to the Clinical Trial Department. The role involves coordinating trial activities, handling clinical documentation, and supporting scientific and marketing efforts related to clinical trials.

The candidate will work with cross-functional teams, vendors, and trial sites to ensure data integrity, timely deliverables, and audit-ready study files. Attention to detail and proactive communication are essential.

Qualifications

• Knowledge of ICH-GCP, ISO 14155 and regulatory guidelines.
• Strong organizational and documentation skills.
• Marketing translation of scientific data and cross-functional coordination.

Responsibilities

• Assist Clinical Trial department with day-to-day activities and maintain trial timelines.
• Prepare, handle, file and archive clinical documentation per SOPs.
• Support scientific activities and marketing collateral development for trials.
• Share scientific materials to support clinical messaging for sales.
• Coordinate internal and external communications for Clinical Trial Department.

Skills

ICH-GCP

ISO 14155

Regulatory knowledge

Ethical guidelines

Organization

Documentation

Multitasking

MS Office

Clinical trial software

Tools

MS Office

Clinical trial software & databases

Job description

ROLES
RESPONSIBILITY

We are seeking a proactive, creative and detail-oriented individual to join our team as an Associate Clinical Trial. In this role, he/she will provide administrative support to the Clinical Trial Department in the full spectrum of the activities such as internal external communication for trial related activities, data document management, stakeholder coordination, communication and coordination for scientific activities, cross functional coordination with supporting departments, marketing translation of scientific data and support for marketing activities, support in execution of marketing activities related to clinical trials and take care of administrative works.

Key Responsibilities

• To assist Clinical Trial department with accurately updating and maintaining clinical day to day activities that ensure compliance and performance within project timelines.
• To assist the clinical team in preparing, handling, distributing, filing, and archiving clinical documentation and reports according to the scope of work standard operating procedures.
• Supporting in scientific activities like scientific session coordination with marketing team, organizers and HCPs wherever applicable
• Take lead in supporting the marketing efforts of the organization by working with the marketing team in developing clinical collaterals
• Providing support to sales force by frequently sharing scientific materials which are handy for passing clinical messaging
• Support in Clinical Trial operations and related activities which help in smooth conduct of the trial
• Preparing presentations for both Clinical Trial Department and for scientific presentations by HCPs
• To coordinate both internally and externally for and on behalf of Clinical Trial Department wherever applicable and within the scope working as a bridge of communications
• To provide general administrative support to the Clinical Operations Department as required.
• To assist the clinical teams in the completion of all required tasks to meet departmental and project goals.
• To assist in the coordination of project management with activities like - expense management, document management, presentations, MIS, etc.
• Maintain comprehensive clinical study documents (Protocol, Informed consent form, Case Report forms and other essential study materials etc.) and ensure proper organization of study files.
• Coordinate and facilitate communication with vendors, stakeholders and trial sites as required.
• Support in reviewing the clinical trial data to ensure accuracy, completeness and integrity.
• Contribute to the preparation of study related presentations by summarizing trial details results based on study protocol and other essential documents.
• Assist in budget tracking and vendor invoice reconciliation as needed.
• Participate and contribute to team meetings and discussions regarding trial progress.
• Ensure study files and documentation are always audit and inspection ready at all times.

Key Skills / Competencies

• Knowledge of ICH-GCP, ISO 14155, global regulatory requirements and ethical guidelines.
• Strong organizational, documentation, and multitasking skills.
• Creative and marketing enthusiast with a good hold on language
• Ability to work effectively in a fast-paced and changing environment.
• Excellent communication and interpersonal abilities for effective collaboration with cross-functional teams and site personnel.Proficiency in MS Office and familiarity with clinical trial software and databases.
• Detail-oriented, proactive, and willingness to learn take on new responsibilities as a team player.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.