Clinical Document Agent

This is a fully remote position, open to applicants in India.

📋 Description

• Develop documentation forms for clinical projects.

• Prepare patient files and transform raw data into electronic format while adhering to established procedures and protocols.

• Create subject files, review templates, meet deadlines, rectify errors prior to transcription, and follow up on client feedback.

• Produce electronic documentation forms for the clinic.

• Recommend and order subject meals throughout the duration of a study and conduct follow-ups.

• Digitize raw study data provided by the Clinical Study Manager.

• Calculate final blood volumes for each subject based on study requirements.

• Verify that subjects have accurate washout-period dates.

• Conduct peer reviews of team members' work.

• Assist in resolving issues related to ongoing tasks.

• Train new team members.

• Communicate with internal and external partners to gather documents necessary to meet deadlines.

• Undertake other assigned clinical responsibilities.

• Ensure that activities are in compliance with relevant corporate and divisional policies, standard operating procedures, and operational guidelines.

⛳️ Requirements

• Bachelor’s or Master’s degree in Life Sciences.

• 1 to 3 years of relevant experience.

• Work Shift timing: 2 PM to 11 PM IST (2nd Shift).

• Understanding of Clinical Trial documentation.

• Experience in Phase 1 studies is required.

• Familiarity with Investigator Site Files (ISF).

• Proven experience in Document Quality Control (QC).

• Proficiency in Excel, including form creation and source documentation development.

• Knowledge of Adobe and strong computer skills.

• Excellent communication abilities.

• Capability to coordinate with cross-functional global teams.

• Ability to comprehend requirements and convert them into documentation.

• Strong computer skills, particularly in Microsoft Word and Excel.

• Exceptional written and verbal communication, presentation, and interpersonal skills.

• Experience in a regulatory context will be considered advantageous.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Flexible remote work arrangement (Remote (Pre-Approved)).