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Senior Clinical Operation Specialist – Sponsor-dedicated
Syneos HealthSenior Clinical Operation Specialist managing clinical monitoring activities and site management compliance for drug development at Syneos Health.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research compliance, including knowledge of ICH/GCP guidelines and medical terminology. Proficient in project management, document maintenance, and effective communication within clinical operations.
Highest-signal resume keywords
Clinical Research ExperienceKnowledge of ICH/GCPAttention to DetailOrganizational SkillsExcellent Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Data ManagementProject File MaintenanceDocument TrackingSite Management ActivitiesFile Audits
Soft Skills
Interpersonal SkillsPresentation SkillsProblem-Solving SkillsAbility to Prioritize Tasks
Tools & Technologies
Clinical Tracking DatabasesShared Mailbox Management
Industry Keywords
Clinical OperationsPharmaBiotechMedical Terminology
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions.
- Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
- Creates and assists with maintenance of project files, handles project correspondence
- Participates in file audits
- Prepares and maintains site manuals, reference tools and other documents
- Maintains, updates, and inputs clinical tracking information into databases
- Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
- Manages shared mailbox, processes site requests and routes correspondence appropriately
- Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
- Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
- Routinely anticipates, identifies and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues
- Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training.
- May provide training or mentorship to more junior level Clinical Operations Specialists (COS).
Requirements
What you’ll need- Associates degree preferred or equivalent
- Experience in clinical research/pharma/biotech or related field considered
- In lieu of degree
- Good knowledge of medical terminology, clinical data, and ICH/GCP preferred
- Ability to successfully prioritize and work on multiple tasks
- Strong attention to detail, accuracy and organizational skills
- Excellent communication, presentation, and interpersonal skills
- Ability to embrace new technologies
- Minimal travel up to 10% may be required
Benefits
Comp & perks- 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.