[Hiring] Site Activation Specialist @Syneos Health

Role Description

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

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

• Works within the forecasted submission/approval timelines and ensures they are complied with.
• Tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached, provides clear rationale for delays.
• Assists with contingency plan to mitigate impact and escalates 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 a timely manner.
• Keeps training records updated accordingly and ensures timesheet compliance.
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/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 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, assists 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

• Experience in clinical trials and site activation.
• Strong understanding of regulatory requirements.
• Excellent communication and negotiation skills.
• Ability to work collaboratively in a team environment.

Requirements

• Proven experience in project management.
• Ability to monitor financial aspects of projects.
• Familiarity with SOPs and WIs.
• Strong organizational skills and attention to detail.

Benefits

• Career development and progression opportunities.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to building an inclusive culture.