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Sr Site Activation Specialist

Syneos Health
Syneos Health
2+ years
Not Disclosed
10 Dec. 18, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Site Activation Specialist
Location: Bulgaria (Home-Based)
Job ID: 24006859
Closing Date: Ongoing

Job Description:

Syneos Health is seeking a Senior Site Activation Specialist to join our team in Bulgaria. This home-based position will be responsible for overseeing country-level deliverables related to clinical trial start-up processes. The Senior Site Activation Specialist will manage local submissions, essential document collection, and regulatory approvals, ensuring quality deliverables and project milestones are met. You will work closely with various teams to ensure the efficient execution of site start-up activities, while maintaining compliance with local regulatory requirements and operational procedures.

Key Responsibilities:

  • Ensure quality deliverables at the country level by managing project requirements and timelines.
  • Forecast submission/approval timelines and track milestone progress in real time, identifying and resolving any delays.
  • Handle financial aspects of the project, ensuring compliance with contract hours and reporting discrepancies.
  • Manage local submissions to regulatory authorities and ethics committees, ensuring compliance with timelines and regulations.
  • Provide ongoing support for vendor management, site activation processes, and contract negotiations.
  • Act as a liaison between site staff and functional teams to resolve issues and maintain project flow.
  • Mentor junior staff, providing guidance on administrative procedures, problem-solving, and technical challenges.
  • Contribute to continuous improvement initiatives within the Site Start-Up (SSU) process.

Qualifications:

  • Bachelor’s Degree or equivalent experience.
  • Deep understanding of clinical trial processes, from Phase II-IV, ICH GCP guidelines, and clinical protocols.
  • Proven experience in clinical trial start-up processes, project management, and vendor management.
  • Strong communication, negotiation, and organizational skills.
  • Ability to mentor junior team members and lead site activation efforts at the country level.