[Hiring] Senior Clinical Operations Specialist / Lead Clinical Operations Specialist @Syneos Health

Role Description

Syneos Health® is seeking a Sr Clinical Operation Specialist / Lead Clinical Operation Specialist (immediate Joiner). This position is home-based and strongly prefers immediate joiners.

• 7–10 years of relevant CTA experience
• CTA experience combined with centralized monitoring exposure is preferred
• Strong operational understanding of clinical research
• Good communication skills and fluency in English
• Must be proactive, resourceful, and a quick learner

Key responsibilities include:

• Support set-up and maintenance of information in Clinical Trial Management Systems and other systems as applicable.
• Update data, timelines, milestones, Ethics Committee / Health Authority authorizations, etc. on an ongoing basis.
• Support (Sr.) CPM with study budget management, ensuring accurate planning, tracking, and reporting of clinical study budget and Grant Plan as applicable.
• Perform Good receipt booking in line with Vendor financial report and study status, as required.
• Support set-up and maintenance of Trial Master File (TMF), ensuring all key documents are present and filed appropriately.
• Track clinical studies/projects/activities progress, ensuring CTMS, TMF, and other systems are up to date.
• Address questions; escalate issues or critical findings to project lead (Sr./CPM).
• Support in External Service Provider coordination, including:
• Set up and coordination of External Service Providers.
• Follow-up with External Service Providers on day-to-day operations.
• Ensure all data is reported to the Clinical Trial Team (CTT).
• Logistical support to study team onboarding process.
• Support in meeting set up, coordination, and meeting minutes.
• Support CTT in study start-up activities, recruitment, and close-out activities as required.
• Champion the implementation of operational changes and transitions as required.
• Additional responsibilities may include:
• Developing monitoring plans and study-specific tools.
• Providing input to eCRF design & review, and other documents and systems.
• Central monitoring and data oversight on assigned clinical study(s).
• Communicating observations, deviations to protocol, safety alerts, quality issues, etc.
• Collaborating with Medical Lead to identify safety trends.
• Preparing and sharing the Central Monitoring Package where applicable.

Qualifications

• 7–10 years of relevant CTA experience
• Strong operational understanding of clinical research
• Good communication skills and fluency in English
• Proactive, resourceful, and a quick learner

Requirements

• CTA experience combined with centralized monitoring exposure is preferred
• Home-based position with immediate joiners strongly preferred

Benefits

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Commitment to building an inclusive culture