[Hiring] Clinical Document Agent @Syneos Health

Role Description

The clinical document agent is responsible for creating the documentation forms for clinical projects, drafting patient files and converting raw data into electronic format while ensuring that pre-established procedures and processes are followed.

Core Responsibilities

• Carry out the full spectrum of activities related to creating subject files, which include tasks such as reviewing templates, ensuring that timelines are adhered to and correcting mistakes before transcription and following up on client comments.
• Generate electronic documentation forms for the clinic.
• Suggest and order subject meals for the length of a study and perform the necessary follow-up.
• Digitalize the raw data from studies transferred by the Clinical Study Manager.
• Calculate the final blood volumes for each subject per study and ensure that each subject participating in a study has the correct dates for their wash out period.
• Perform peer review for the work performed by the team.
• Help to resolve problems related to the work being performed.
• Provide training to new team members.
• Contact the various collaborators both within and outside of the department in order to obtain the documents necessary for meeting timeframes.
• May be assigned other clinical tasks.
• Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.

Qualifications

• Bachelor / Master’s degree in a Life Sciences
• 1 to 3 years of experience
• Work Shift timing: 2 PM to 11 PM IST (2nd Shift)
• Understanding of Clinical Trial documentation
• Phase 1 experience is a must
• Knowledge of Investigator Site Files (ISF)
• Must have experience in Document QC
• Must have experience in Excel, creating forms and creating source documentation in Excel
• Knowledge of Adobe, computer skills
• Excellent Communication skills
• Ability to coordinate with cross-functional global teams
• Ability to understand requirements and translate them into documentation

Requirements

• Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Experience in regulatory context will be considered an asset

Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.