Site Activation Specialist I - Sponsor-dedicated; home-based

3015 Syneos Health Poland sp. z o.o.; Polska; Hybrid; PLN 60,000 - 90,000; Full time

Benefits offered by this job

Career development

Inclusive culture

Total rewards program

Job summary

Syneos Health is seeking a Site Activation Specialist I to support site and investigator evaluation, regulatory submissions, and activation activities. This role involves coordinating with country start-up advisors and managing documentation to ensure timely study delivery in a home-based setting.

The position emphasizes attention to regulatory requirements, risk identification, and collaborative problem solving within a global life sciences team.

Qualifications

• Strong analytical and investigative mindset; ability to review information from multiple sources and identify potential risks.
• Excellent attention to detail and commitment to accuracy in documentation and data entry.
• Sound professional judgment to distinguish between factual findings and potential disqualifying findings.

Responsibilities

• Support site and investigator evaluation activities by collecting, reviewing and assessing regulatory, compliance, quality and performance information.
• Identify potential risks and escalate concerns; collaborate with internal stakeholders to ensure timely resolution.
• Oversee end-to-end site activation process at country/site level, coordinating with CSA/SAM.

Skills

Analytical mindset

Attention to detail

Professional judgment

Process adherence

Time management

Written communication

Repetitive work handling

Quality control

Job description

Site Activation Specialist I - Sponsor-dedicated; home-based 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.

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

Role summary: Supports site and investigator evaluation activities by collecting, reviewing and assessing regulatory, compliance, quality and performance information to support site selection, study start-up and ongoing study delivery. Identifies potential risks, escalates concerns and collaborates with internal stakeholders to ensure timely resolution. 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.

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

• Strong analytical and investigative mindset with the ability to review information from multiple sources and identify potential risks.
• Excellent attention to detail and commitment to maintaining accuracy in documentation and data entry.
• Sound professional judgment with the ability to distinguish between factual findings, items of note, and potential significant or disqualifying findings.
• Ability to follow established processes while recognizing when escalation is required.
• Strong organizational and time management skills with the ability to manage competing priorities and meet deadlines.
• Clear written communication skills, including documenting rationale, evidence, and outcomes in a concise and traceable manner.
• Comfortable with repetitive work and structured processes.
• Able to maintain quality and focus while performing similar assessments repeatedly.

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. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.