Clinical Operations Lead: Site & Study Coordination

Syneos Health, Inc.; Germany (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Syneos Health is seeking an Clinical Operation Specialist to support site management, TMF maintenance, and cross-functional collaboration across clinical studies. You will ensure compliance with SOPs, coordinate with monitoring teams, and maintain essential study documents.

The role requires a High School diploma, strong communication skills, and the ability to learn new technologies, with up to 25% travel. Join a team dedicated to delivering safe, high-quality clinical operations work.

Qualifications

• High School diploma or equivalent.
• Good communication and interpersonal skills.
• Ability to embrace new technologies.
• Minimal travel up to 25% may be required.

Responsibilities

• 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 Trial Master File (TMF) and project files, including participation 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.
• May handle receipt, tracking and disposition of Case Report Forms and Queries.
• Maintains overall awareness in the field of clinical research by completing all necessary and assigned training.

Skills

Communication skills

Interpersonal skills

Tech-savvy

Travel flexibility

Education

High School diploma or equivalent

Job description

Syneos Health is seeking an Clinical Operation Specialist to support site management, TMF maintenance, and cross-functional collaboration across clinical studies. You will ensure compliance with SOPs, coordinate with monitoring teams, and maintain essential study documents.

The role requires a High School diploma, strong communication skills, and the ability to learn new technologies, with up to 25% travel. Join a team dedicated to delivering safe, high-quality clinical operations work.