Syneos Health
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
Clinical Trial Associate – Single Sponsor Support
🔥 10 minutes ago
📊 Check your resume score for this job
Improve your chances of getting an interview by checking your resume score before you apply.
Syneos Health
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
📋 Description
• 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 and tracks milestone progress in agreed upon SSU tracking system in real time • Investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and 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 • Responsible for the Local Submissions Specialist - 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
🎯 Requirements
• 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
• Health benefits to include Medical, Dental and Vision • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) and sick time
Apply NowSimilar Jobs
🕒 June 25
Clinical Trial Associate managing multiple tasks in Rater Training Program for clinical trials at Cogstate. Ensuring successful communication between various stakeholders and effective project execution.
