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

Perform activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures (SOPs), Work Instructions (WIs), and GCP & ICH Guidelines.

Assists with maintenance of Trial Master File (TMF), perform TMF document process activities such as preparing documents, submission, re-classifying, deleting duplicate documents, and editing metadata.

Perform thorough ALCOA quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues or queries identified.

o ALCOA (Attributable, Legible, Contemporaneous, Original & Accurate)

Maintain timely and effective communication with study team regarding assigned task & deliverables.

Assist study teams with administrative and clerical task such as:

o Study Filing (i.e. Study Team Curriculum Vitae (CVs), Study Correspondence, Monitoring Reports, Monitoring Letters, & Telephone Contact Reports
o Management of helpdesk tickets requesting and revoking access to systems (i.e. Electronic Data Capture, Clinical Trial Management System (CTMS))
o CTMS Site Information Entry
o Provide Study Specific Training Compliance Reports
o Formatting Study Team Newsletters
o CV conversions to one page (if required)
o Preparation of draft IRB application form & package for IRB submission of safety reports
o Preparation of the required documents for SIV, IMV and COV
o Support payment of investigator fee and IRB review fee
o Support the document translation process, including requesting quotes from translation vendors

Maintain compliance with departmental quality, performance and utilization targets.

Support logistics for department and/or external meetings accordingly

Prepare and produce materials and presentations for Manager/Mentor meetings as requested

Collaborate with interns/colleagues from other regions of the world and learn from their job scopes

Assist with data collection and analysis

Performs other work-related duties as assigned.

Qualifications

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.

Qualification

Degree in the biological sciences or related discipline in the natural sciences/health care preferred

Administrative Experience.

Ability to embrace new technologies.

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, database applications), email, and internet

Strong communication and presentation skills, interpersonal skills, as well as a team oriented approach

Excellent verbal, written, communication and time management skill.

Ability to multitask under tight deadlines on several projects with specific and unique requirements, while providing attention to detail and high quality work

Ability to be flexible, adapt to change, work independently, as well as work as part of a team in a matrix environment.

Proficiency in the English language both written and verbal.

Minimal clinical or research experience preferred.

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