[Hiring] Country Start-up Specialist @Syneos Health

Role Description

Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager. Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached: investigates and provides clear rationale for delays, provides support on 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 (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
• Responsible for the 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 PM/SAM (or designee) during start-up on allocated projects.
• Complies 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.
• 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 moderate 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.

Country Start-Up Advisor - Acts as Subject Matter Advisor for in-country performance within the Site Start-Up. Supports country-level intelligence on start-up (SU) and clinical trial regulatory (CTR).

• Ensures that local country regulatory intelligence, as it pertains to the activities of the local SU and CTR team, is maintained on the central repository.
• Provides support for data protection at the country and provides guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements.
• Provides input in local SOPs and WI.
• Supports the creation of internal training materials on local legislation requirements.
• Provides input to the team to assist with EC or CA issue resolution at the country 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 – Provides support to SAM to agree on country template contract and budget.
• Produces site-specific contracts from country template.
• Provides support in submissions for proposed contract and budget for site.
• Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SAM with Sponsor until resolution of issues and contract execution.
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.

Qualifications

• Experience in Clinical Research, Study Start-Up, Regulatory Affairs, Clinical Operations, or related functions.
• Demonstrated experience managing country start-up activities, including regulatory and ethics committee submissions, essential document collection, and study activation processes.
• Experience supporting study maintenance activities, including protocol amendments, continuing reviews, safety submissions, renewals, and ongoing regulatory compliance.
• Strong understanding of ICH-GCP guidelines and local regulatory requirements.
• Experience working with multiple stakeholders, including sponsors, CROs, investigator sites, and regulatory authorities.
• Strong project management and organizational skills.
• Strong written and verbal communication and interpersonal skills.
• Coordinate country start-up activities from study award through site activation.
• Prepare and submit regulatory and ethics committee packages to support study initiation.
• Track country and site activation timelines, ensuring milestones are achieved according to project plans.
• Manage ongoing study maintenance activities, including amendments, renewals, annual reports, and essential document updates.
• Support sites throughout the lifecycle of the study, ensuring continuous regulatory compliance and operational readiness.

Benefits

• Company car or car allowance.
• Health benefits to include Medical, Dental, and Vision.
• Company match 401k.
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonus based on company and individual performance.
• Flexible paid time off (PTO) and sick time.

Salary Range

$56,400.00 - $95,900.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.