Description

Senior CTA Start up specialist. 

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

SUBMISSION

- (amendments, revisions) and follow-up

INFORMED CONSENT

- HCI- Legal Review and/or Communication with SNN / AbbVie Legal Department

REGULATORY

- Obtain and process regulatory documents from investigator sites and suppliers (e.g. completed FDA 1572 form, CVs, IRB / EC approval for informed consent and study, lab certifications, etc...).

- PI (investigational product) documentation for medication release - Annual updates including country scope and essential document reviews.

PROJECT FEASIBILITY

- Contact with sites and use of experience from other research conducted to determine estimated timelines and identify potential impediments to study completion. - CDA: Draft, Negotiate, Approve, Execute, Monitor and Report (includes site preparation time) site selection / feasibility / CDA.

Qualifications

What we’re looking for
•    Associates degree preferred or equivalent
•    3-4 years of experience in Start-up 
•    Good knowledge of medical terminology, clinical data, and ICH/GCP preferred
•    Ability to successfully prioritize and work on multiple tasks
•    Strong attention to detail, accuracy and organizational skills
•    Excellent communication, presentation, and interpersonal skills
•    Ability to embrace new technologies
•    English fluent

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.