Syneos Health

Sr Clin Ops Specialist - Global Submissions

5 days left

Client-Based, GBR
16 Apr 2021
16 May 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Senior Clinical Operations Specialist

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.

Working from the client's offices in Middlesex (post COVID), you will be joining a new team focused on the planning and the preparation of the clinical trial applications package for EU submissions. Ths is a great opportunity to join an innovative and dynamic environment.

Job responsibilities

Responsible for the planning and the preparation of the clinical trial applications package (CTAp) for programs conducted mainly in the EU with focus on Substantial amendments coordinating updates at program level.

The specialist will gain expertise to progressively be assigned to initial applications of increasing complexity.

1.Assist with the preparation distribution and tracking of the core Clinical Trial Application dossier and subsequent amendments (IB/CMC at program level + revised protocols).
2.Assist with Verity (HA submission and approval Tracking system) by creating events/activities/registrations/running reports etc.
3.Ensure consistency of the Clinical Trial application across projects studies and countries
4.Actively participate in Program level CTAp Tracking Meetings led by senior role in preparation of the CTAp dossier ensuring timelines and dossier quality are managed according to expectations
5.Escalate to study teams and senior roles observed trends and issues that may impact timely and successful study approval and execution.
6.Expected to be able to coordinate updates within a Program.
7.Support continuous improvement and compliance initiatives.
8.Utilizes technology effectively to support the clinical trial application submission process. Proficient use of CTMS Tracking systems Excel trackers to generate reports and track the CTAp content and associated dates.

EU process and package content is an asset. experience in effective implementation of clinical plans/documents and document preparation. previous experience working in an international team environment within a matrix organization Fluent in English (written and spoken)

• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
• Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
• Creates and assists with maintenance of project files, handles project correspondence
• Participates in file audits
• Prepares and maintains site manuals, reference tools and other documents
• Maintains, updates, and inputs clinical tracking information into databases
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
• Manages shared mailbox, processes site requests and routes correspondence appropriately
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
• Routinely anticipates, identifies and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues
• Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training.
• May provide training or mentorship to more junior level Clinical Operations Specialists (COS).

#LI-NC1What we're looking for
• Associates degree preferred or equivalent
• Experience in clinical research/pharma/biotech or related field considered In lieu of degree
• Experience of the pharmaceutical industry (thorough understanding of ICH-GCP guidelines) and of the pre-clinical clinical regulatory and commercial components the drug development process and the impact of regulations worldwide. knowledge of general clinical research including project management issues important milestones and strategies to ensure timelines are met. experience in Clinical Trial Application preparation and coordination regulatory or equivalent in the pharmaceutical industry.
• EU process and package content is an asset. experience in effective implementation of clinical plans/documents and document preparation. previous experience working in an international team environment within a matrix organization Fluent in English (written and spoken)
• Strong attention to detail, accuracy and organizational skills
• Excellent communication, presentation, and interpersonal skills
• Experience of preparing clinical trial applications package for submissions.

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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