Syneos Health

Project Specialist - Global Clinical Trial Submissions

Client-Based, GBR
20 Apr 2021
20 May 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Project Specialist (Global Clinical Trial Submissions)

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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.

This is a sponsor dedicated role working embedded with one of our well respected Pharmaceutical clients in Middlesex. The role will be part office based / part home based (post COVID).

Job responsibilities

- Coordinate and prepare the documents needed for initial submission and Substantial amendments of study package for all countries (except US) in compliance with the Country Regulatory Requirements, EU Directive 2001/20/EC, related Guidance, and internal processes.
-Determine the appropriate submission strategy and consistency of the CTAp across projects, studies and countries.
-Effectively Lead Clinical Trial Application Tracking Meetings for the preparation of the CTAp dossier during start-up with cross-functional team and assure timelines and dossier quality are managed according to expectations.
-Liaise with local and central teams and CRO as required to ensure that study start up activities are in compliance with study timelines and local regulations.
- Optimally compile and distribute the final Clinical Trial Application dossier (CTAp and subsequent Substantial amendments to country applicants for submission to Ethics Committees and Competent Authorities.
- Comply with the use and maintenance of the available planning & tracking tools (e.g. IRIS) to generate reports and track the CTAp content and associated dates.
- Contribute to the Country Requirements Repository by collecting and sharing additional country requirements.
- Ensure Compliance with any revised Guidance & Regulations at EU and Country levels.
#LI-NC1What we're looking for
Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience
*Good clinical research experience and knowledge of ICH-GCP
*Team player
*Ability to work on multiple protocols simultaneously
*Flexible/adaptable to changing priorities
*Project planning/management experience

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. 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.


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