Trial Master File Specialist (ideal opportunity for CTAs) assigned to client Arg

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.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

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

• Process study documentation in accordance with applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and executed study-specific processes/requirements.
• Support the set-up, maintenance, and closure of TMF repositories.
• Support documentation collection activities, including:
  • Document scanning and indexing for trial using an electronic TMF.
  • Ensures the security and compliance of all documents related to active and archived projects.
• Perform Quality Review of documents submitted to the TMF.
• Perform Completeness Review of TMF content against Expected Document Lists to determine missing TMF content.
• Paper Document and Document Control Room (DCR) Management:
  • Perform Scanning, indexing and Quality Review and Filing of Hard copy documents
  • Process requests for Hardcopy documents, ensuring timely and appropriate delivery to the requestor, and timely and accurate re-filing upon return.
  • Ensures all applicable paperwork is completed upon release and return of each project document and/or project file from the DCR.
  • Ensures the DCR is kept tidy and in an inspection ready state at all times.
• Liaise with document owners to resolve any issues identified.
• Escalate issues to the TMF Lead as required and Complete administrative tasks (e.g., status reporting) as requested.
• Participate in preparation/reconciliation of TMF documentation related to audits, inspections, and shipments.
• Participate in process and study specific trainings as required.
• Maintain compliance with company standard requirements (e.g., time tracking, training), as well as role-specific requirements (e.g. Quality, Productivity, utilization)
• Create and cross reference compliance tools/trackers that have been developed to complete compliance check.
• Add placeholders for missing documents.
• Ability to work with limited supervision.
• Perform other work-related duties as assigned. Occasional travel may be required (up to 10%).

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.