Site Activation Specialist with payment experience in Clinical Trials (Client Dedicated, Remote - CAN)

Syneos Health; Canada; Remote; CAD 65,000 - 90,000; Full time

Job summary

Syneos Health is seeking a Site Activation Specialist with payment experience to join our Clinical Solutions team in a remote CAN setting. You will support start-up activities for investigational sites, manage regulatory submissions, and ensure timely delivery of essential documents.

The role involves coordination with country teams and sponsors to drive efficient site activation across clinical studies. Responsibilities include monitoring submission timelines, maintaining TMF records, and

Qualifications

• Experience with site activation in clinical trials.
• Familiarity with regulatory submissions and essential documents.

Responsibilities

• General – Deliver quality country-level outputs under SSU guidance.
• Monitor submission timelines and track milestones in SSU systems; escalate delays with contingency plans.
• Submit Trial Master File documents per SOPs and sponsor requirements.
• Support local EC/RA submissions and site activation end-to-end at country level.

Skills

Site Activation

Clinical Trials

Regulatory Submissions

Job description

Description

Site Activation Specialist with payment experience in Clinical Trials (Client Dedicated, Remote - CAN)

Site Activation Specialist with payment experience in Clinical Trials (Client Dedicated, Remote - CAN)

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

General – Responsible for providing quality on deliverables at the country level and follows projectrequirements and applicable country rules, with oversight from the SSU Country Manager.

• Works within the forecasted submission/approval timelines and ensures they are complied with andtracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines arenot reached provides clear rationale for delays, assists with contingency plan to mitigate impact, andescalates the issue as soon as identified.


• Monitors basic financial aspects of the project and the number of hours/tasks available per contract;escalates discrepancies in a timely fashion.


• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in atimely manner, keeps training records updated accordingly and ensures timesheet compliance.


• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per CompanySOP/Sponsor requirements.

Responsible for one or more of the following functions at the country level:

• Local Submissions Specialist - Follows the project direction provided by the designated country startup advisor (CSA) and SAM. May serve as a point of contact for the SAM/PM (or designee) during startup on allocated projects. Compiles and/or reviews essential document packages for site activation andmay also be involved in essential document collection from site.


• Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other localregulatory 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 asrequired 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 ensurethat the appropriate sites are selected for individual studies based on the requirements of the clinicaltrial.


• May be asked to perform: Local Investigator Contract and Budget Negotiator – Supports the SAM toagree on country template contract and budget. Assists in producing site-specific contracts fromcountry template. Under supervision assist in negotiations of budget and contract with site and via SiteContracts 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 intorepositories and capture of metadata.

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.

Summary

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: investigator site contracts, 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.