Syneos Health

Senior Site Start-Up & Regulatory Specialist

Syneos Health

full-time

Posted on:

Location Type: Remote

Location: South Africa

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Job Level

Senior

About the role

  • responsible for quality deliverables at the country level; follows project requirements and applicable country rules, with minimal oversight from the ssu country manager.
  • forecasts submission/approval timelines, ensures compliance and tracks milestone progress in agreed upon ssu tracking system in real time; if forecasted timelines are not reached analyses data to provide clear rationale for delays, provides contingency plans to mitigate impact, and escalates the issue as soon as identified.
  • monitors 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.

Requirements

  • local submissions specialist - follows the project direction and expertise provided by the designated country start-up advisor (csa) and pm/sam.
  • may serve as the primary point of contact for the pm/sam (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.
  • oversees 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 minimal 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.
Benefits
  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
project managementdata analysisfinancial monitoringregulatory submissionsdocument managementcompliance trackingmilestone trackingcontingency planningsite activationsops compliance
Soft Skills
communicationproblem-solvingattention to detailorganizational skillscollaborationtime managementadaptabilityleadershipinterpersonal skillsfacilitation