Clinical Trial Associate

About the Role

We are seeking a proactive, creative, and detail-oriented individual to join our team as an Associate Clinical Trial. In this role, you will provide administrative support to the Clinical Trial Department across a full spectrum of activities.

Key Responsibilities

• Provide administrative support for internal & external communication for trial-related activities.
• Manage data & document management for clinical trials.
• Coordinate with stakeholders and support scientific activities.
• Facilitate cross-functional coordination with supporting departments.
• Assist in the marketing translation of scientific data and support marketing activities.
• Support the execution of marketing activities related to clinical trials.
• Assist the Clinical Trial department with accurately updating and maintaining day-to-day activities to ensure compliance and performance within project timelines.
• Assist the clinical team in preparing, handling, distributing, filing, and archiving clinical documentation and reports according to the scope of work and standard operating procedures.
• Support in scientific activities such as scientific session coordination with the marketing team, organizers, and HCPs.
• Take a lead in supporting the organization's marketing efforts by working with the marketing team to develop clinical collaterals.
• Provide support to the sales force by frequently sharing scientific materials for clinical messaging.
• Support clinical trial operations and related activities for smooth trial conduct.
• Prepare presentations for the Clinical Trial Department and for scientific presentations by HCPs.
• Coordinate both internally and externally for and on behalf of the Clinical Trial Department, acting as a bridge for communications.
• Provide general administrative support to the Clinical Operations Department as required.
• Assist clinical teams in completing all required tasks to meet departmental and project goals.
• Assist in project management activities, including expense management, document management, presentations, and MIS.
• Maintain comprehensive clinical study documents (Protocol, Informed consent form, Case Report forms, and other essential study materials) and ensure proper organization of study files.
• Coordinate and facilitate communication with vendors, stakeholders, and trial sites.
• Support in reviewing clinical trial data to ensure accuracy, completeness, and integrity.
• Contribute to the preparation of study-related presentations by summarizing trial details and results based on the study protocol and other essential documents.
• Assist in budget tracking and vendor invoice reconciliation.
• Participate and contribute to team meetings and discussions regarding trial progress.
• Ensure study files and documentation are always audit and inspection ready.

Requirements & Tech Stack

• MS Office proficiency.
• Familiarity with clinical trial software and databases.

Qualifications

• 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.
• Detail-oriented, proactive, and willingness to learn and take on new responsibilities as a team player.