- Location
- BGR-Sofia-Hybrid, Bulgaria
- Workplace
- Hybrid, Remote
- Type
- Full-time
- Education
- Bachelor
- Source
- Workday
Description
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
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 deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
The role will be dedicated to one single client and it will require attendance at client offices based in Sofia.
Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for the delivery, with oversight from the Line Manager in one or more of the following functional areas: ethics and regulatory submissions, collection and review of essential documents required for site initiation and site activation activities. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs) under the supervision of the Project Lead (PL) or Site Activation Manager (SAM) as appropriate, may directly interact with Customers regarding requirements from RA or other local regulatory party. Accountable to the PL/SAM at the project level and line manager for deliverables.
JOB RESPONSIBILITIES
Responsible for one or more of the following functions at the country level:
- Coordinate site start-up and activation activities to ensure studies are initiated on time and to quality standards.
- Manage regulatory, ethics, and essential document submissions while ensuring compliance with applicable requirements.
- Collaborate with cross-functional teams to resolve issues, mitigate risks, and support timely site activation.
- Oversee site activation milestones, including supply management, IP release, and site readiness approvals/greenlights.
- Track progress, maintain study metrics and databases, provide status updates, and support audit readiness and process improvements
QUALIFICATION & REQUIREMENTS
- Bachelor's Degree required, degree in health care or scientific field preferred
- A minimum of 1-2 years of clinical research experience and preferably 1+ years of study start up management experience for the designated region. - EUCTR/CTIS experience will be a Plus.
- Good 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, including Word, Excel, PowerPoint, Publisher.
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.