Sponsor-dedicated Site Activation Specialist I - Home-based, fixed-term

Syneos Health, Inc.; Polska; Hybrid; PLN 60,000 - 90,000; Part time

Job summary

Syneos Health, Inc. seeks a Sponsor-dedicated Site Activation Specialist I to support regulatory submissions and site activation from home. The role collaborates with country teams, PMs, and sites to ensure timely activation and compliant documentation.

Responsibilities include EC/RAs submissions, feasibility support, and assisting in budget/contract negotiations. A good clinical trial understanding and strong organizational skills are essential for success in this fixed-term, remote position.

Qualifications

• Associate’s Degree or equivalent combination of education and training.
• Good understanding of the clinical trial process across Phases II–IV and ICH GCP.
• Ability to interact effectively with investigative site personnel.
• Good organizational skills and attention to detail; ability to handle multiple tasks.
• Ability to take direction from multiple people and set priorities accordingly.
• Ability to communicate across clinical teams, PM, and Director.
• Demonstrated ability to work independently as well as in a team.
• Quality-driven in all managed activities.
• Flexibility to adapt to a rapidly changing environment and learn new functions.

Responsibilities

• Local Submissions Specialist: follow project direction; compile/review essential document packages for site activation.
• Prepare and submit Central/Local EC Applications and RA submissions under supervision.
• Oversee site activation end-to-end at country/site level.
• Support Local Site ID and Feasibility activities with PM/SAM.
• Assist in negotiations of country contract templates and site budgets; coordinate with Site Contracts Service Centre.
• Maintain quality control and archive documents with metadata in repositories.

Skills

Communication

Organization

Problem solving

Teamwork

Adaptability

Attention to detail

Independent work

Multi-tasking

Analytical thinking

Quality driven

Education

Associate’s Degree or equivalent

Tools

Word

Excel

PowerPoint

Publisher

Job description

Sponsor-dedicated Site Activation Specialist I - Home-based, fixed-termSyneos 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**Responsible for one or more of the following functions:* Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SAM. May serve as a point of contact for the SAM/PM (or designee) during start-up on allocated projects. Compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from site.* Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with oversight from the SSU Country Manager.* May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversee site activation end to end process at country/ site level.* Local Site ID and Feasibility Support – Provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.* May be asked to perform: Local Investigator Contract and Budget Negotiator – Supports the SAM to agree on country template contract and budget. Assists in producing site-specific contracts from country template. Under supervision assist in negotiations of budget and contract with site and via Site Contracts Service Centre and SAM lead with Sponsor until resolution of issues and contract execution. Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. Qualifications:* Associate’s Degree or equivalent combination of education and training* 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.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.