Country Study Startup Specialist – Part Time

Syneos Health

Country Study Startup Specialist managing clinical trial processes and ensuring quality deliverables at country level for Syneos Health. Collaborating with the Clinical Solutions team to navigate complex regulations.

Posted 7/9/2026part-timeBucharest • 🇷🇴 RomaniaMid-LevelSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Responsible for the quality deliverables at the country level
follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager
Works within the forecasted submission/approval timelines and ensures they are complied with
tracks milestone progress in agreed upon SSU tracking system in real time
if forecasted timelines are not reached: investigates and provides clear rationale for delays
provides support on contingency plan to mitigate impact
escalates the issue as soon as identified
Monitors basic 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 (WI) in a timely manner
keeps training records updated accordingly and ensures timesheet compliance
Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned
Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements
Follows the project direction provided by the designated country start-up advisor (CSA) and SAM
May serve as a point of contact for the PM/SAM (or designee) during start-up on allocated projects
Complies 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
Prepares 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 moderate 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

Requirements

What you’ll need

Bachelor’s Degree
Detailed understanding of clinical trial process across Phases II-IV and ICH GCP
Ability to understand clinical protocols and associated study specifications
Detailed understanding of clinical trial start-up processes
Ability to manage external vendors to contract effectively
Strong organizational skills with ability to handle multiple tasks effectively
Strong written and verbal communication and interpersonal skills
Ability to manage multiple project budgets with increased complexity and value
Quality-driven in all managed activities
Good negotiating skills
Good problem-solving skills
Demonstrated ability to work independently as well as part of a team

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Clinical Trial Start-Up ProcessesICH GCP ComplianceClinical Protocol UnderstandingVendor ManagementBudget Management

Soft Skills

Problem-Solving SkillsNegotiating SkillsInterpersonal SkillsTeam CollaborationIndependent Work

Certifications

Bachelor’s Degree