Clinical Document Agent

Clinical Document Agent

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• 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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

Job Summary
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 mistake 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.
•  Digitalizes 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.
•  Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist but is not intended as a wholly comprehensive or permanent representation.

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 must

- Knowledge of Investigator Site Files (ISF)

- Must have exp in Document QC

- Must have experience in Excel, creating forms and creating source documentation in Excel

- Knowledge adobe, computer skills

- Excellent Communication skills

- Ability to coordinate with cross-functional global teams

- Ability to understand requirements and translate them into documentation

- Candidates with TMF Lead experience may also be considered

Critical Skills:

• 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

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.