Clinical Document Agent

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

📋 Description

• Develop documentation forms for clinical initiatives.

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

• Evaluate templates, comply with timelines, rectify errors prior to transcription, and follow up on client feedback.

• Create electronic documentation forms for the clinic.

• Recommend and arrange subject meals throughout the study duration and conduct follow-ups.

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

• Compute final blood volumes for each participant in the study.

• Verify that subjects have accurate washout-period dates.

• Conduct peer reviews of team members' work.

• Assist in resolving work-related issues.

• Mentor new team members.

• Reach out to internal and external collaborators to gather necessary documents to meet deadlines.

• May undertake additional clinical responsibilities.

• Ensure adherence to Corporate and Divisional Policies, Standard Operating Procedures, and Operating Guidelines.

• Carry out other tasks as assigned by management.

⛳️ Requirements

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

• 1 to 3 years of relevant experience.

• Familiarity with Clinical Trial documentation.

• Experience in Phase 1 trials is essential.

• Knowledge of Investigator Site Files (ISF).

• Experience in Document Quality Control (QC).

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

• Competence in Adobe and strong computer skills.

• Outstanding communication abilities.

• Capability to collaborate with cross-functional global teams.

• Ability to comprehend requirements and convert them into documentation.

• Candidates with TMF Lead experience may also be eligible.

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

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

• Experience in a regulatory context will be regarded as an advantage.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations, where applicable, to assist employees or applicants with disabilities.