TMF Specialist (Safety processing) - Min 2 years of previous exp in in central file management - Argentina, 100% home-based

TMF Specialist (Safety processing) - Min 2 years of previous exp in in central file management - Argentina, 100% home-based

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.

Discover what our 29,000 employees, across 110 countries already know.

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. 

Job Responsibilities

• The scope of this role is exclusively to process and review safety documents only
• Process TMF documents received per good documentation practices, TMF readiness criteria and other reference documents
  • Demonstrate understanding of document types, properties and indexing requirements
  • Ensure overall TMF quality in terms of document completeness, indexing and scanning accuracy
  • Process documents in the TMF system(s) within specified timelines, based on document criticality/priority
  • Communicate document inquiries with responsible users as needed
• Liaise with Document Owners, TMF Study Owners and/or other end users to resolve document related discrepancies and issues
• Communicate and escalate issues to the TMF Document Specialist Lead and TMF Operations when needed
• Contribute to process improvement initiatives and projects that may arise
• Can be identified as Subject Matter Expert for TMF process, systems and related tools, where applicable

Qualifications

• Minimum of a Bachelor’s degree or equivalent
• English advanced, global stakeholders
• Minimum of 2 years of relevant experience in central file management for clinical trials .
• Experience in the pharmaceutical industry or at a CRO in a similar role.
• Experience working in a global environment, as the role involves communicating with the Asia-Pacific team.
• Solid knowledge of ICH/GCP documents requirements
• Effective verbal and written communication skills with internal and external teams.
• Strong technical proficiency and the ability to learn and use various systems.

We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

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.

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.

Summary

The TMF Document Specialist is responsible for ensuring the quality of documents in the TMF system. The TMF Document Specialist will accurately identify and process TMF documents in a timely manner and assist in the remediation of document issues with Document Owners/TMF Study Owners or other end users.