Description

Sponsor Dedicated Site Activation Specialist - Bulgaria

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

This role will be managing Investigator Initiation Package/ Investigational Product Release Form/ Activation Greenlight Form to approval, following Sponsor indication and quality procedures. The package will include regulatory documents- CVs, FDF, FDA 1572, GCP trainings

The SAS pre-fill and distribute such essential documents to sites, review/QC completed documents for consistency, and assemble the whole pack (up to 40 docs/site at start up) for approval so that the site can receive the study-drug and start screening.

leading and collaborating on local and central Institutional Research Board (IRB) / Institutional Ethics Committee / Central Ethics Committee activities for countries in scope- including answering queries from such authoritiesmanaging protocol amendments and essential document updates throughout lifecycle of the study.site interaction and working with sites and site personnel to complete study documents at the expected quality

What we are looking for?

Associate degree or equivalent combination of education and training. Familiarity with above tasks and with local (Bulgarian) study start up processesGood understanding of clinical trial process across Phases II-IV and ICH GCP, Ability to interact effectively and appropriately with investigative site personnel. Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively. Ability to take direction from multiple individuals and set priorities accordingly. Ability to effectively communicate across multiple function groups (clinical team, PM, Director).Demonstrated ability to work independently, as well as part of a team. Utilize problem-solving techniques effectively. Quality-driven in all managed activities. Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions. Strong computer skills

We are always excited to connect with great talent. This posting is intended for an possible upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available

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.

http://www.syneoshealth.com

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.