Address
Form of workTrial Master File (TMF) Document Specialist I
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
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
Job responsibilities
• Process study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study specific TMF Plans.
• Support the set-up, maintenance, and closure of TMF repositories.
• Support documentation collection activities, including:
o Document scanning and indexing for trial using an electronic TMF
o Document filing for trials using a paper TMF
• Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified
• Maintain compliance with departmental quality, performance and utilization target
• Complete administrative tasks (e.g., status reports) as requested
• Maintain compliance with company requirements (e.g., time tracking, training)
• Participates in preparation/reconciliation of TMF documentation related to audits, inspections and shipments.
• Participates in study specific training as required.
• For Paper documents, responds promptly to each request received for a project document or project file, ensures timely and appropriate delivery to the requestor, and timely and accurate re-filing upon return. Ensures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room
• Ensures the security and compliance of all documents related to active and archived project
• Performs other work-related duties as assigned. Occasional travel may be required (up to 10%).
Qualifications:
What we're looking for
• High school education, some college courses in the scientific/regulatory field preferred.
• Some experience in a clinical trials environment preferred.
• Some knowledge of applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology preferred.
• Familiarity with electronic TMF system preferred. Strong verbal, written and organizational skills with a team-oriented approach.
• Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment.
• Proficiency in Microsoft Office Suite and Adobe Acrobat.
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.
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
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 Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study specific TMF Plans.
• Support the set-up, maintenance, and closure of TMF repositories.
• Support documentation collection activities, including:
o Document scanning and indexing for trial using an electronic TMF
o Document filing for trials using a paper TMF
• Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified
• Maintain compliance with departmental quality, performance and utilization target
• Complete administrative tasks (e.g., status reports) as requested
• Maintain compliance with company requirements (e.g., time tracking, training)
• Participates in preparation/reconciliation of TMF documentation related to audits, inspections and shipments.
• Participates in study specific training as required.
• For Paper documents, responds promptly to each request received for a project document or project file, ensures timely and appropriate delivery to the requestor, and timely and accurate re-filing upon return. Ensures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room
• Ensures the security and compliance of all documents related to active and archived project
• Performs other work-related duties as assigned. Occasional travel may be required (up to 10%).
Qualifications:
What we're looking for
• High school education, some college courses in the scientific/regulatory field preferred.
• Some experience in a clinical trials environment preferred.
• Some knowledge of applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology preferred.
• Familiarity with electronic TMF system preferred. Strong verbal, written and organizational skills with a team-oriented approach.
• Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment.
• Proficiency in Microsoft Office Suite and Adobe Acrobat.
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.
