CST Project Manager (eCOA Manager)
New
S
Syneos HealthClinical research
Remote SERBIAFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- High level of competency in English language.
- Required Skills
- MS Office
Requirements
- Bachelor’s degree or equivalent qualification in Life Sciences, Medicine, Pharmacy, Nursing, or a related field preferred.
- Prior experience in study coordination, a contract research organization (CRO), pharmaceutical or biotechnology company, or rater training vendor preferred.
- High-level competency in English.
- Proficiency with MS Office applications.
- Strong knowledge of Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and other applicable regulatory requirements.
- Excellent written and spoken communication, presentation, and interpersonal skills.
- Strong organizational, planning, customer service, and time-management skills, with attention to detail and ability to multitask under tight deadlines.
- Ability to manage time and work independently.
- Ability to travel as necessary, up to 25%.
Responsibilities
- Represent the CST team on studies and programs, collaborating with functional groups, vendors, license holders, KOLs, and Sponsors.
- Manage CST vendor deliverables, scale licensing and translation, and paper scale worksheet development.
- Manage CST service documentation and templates, including development and testing of the Study Training and Engagement Portal (STEP) when needed.
- Develop and maintain study-specific CST plans in line with SOPs and WIs, and align relevant functional project plans.
- Provide status updates to internal and Sponsor teams and act as a contact for CST-related project issues.
- Create and maintain CST metric reports and ensure project documentation is filed accurately in the Trial Master File (TMF).
- Identify project risks and develop mitigation plans; participate in audits and inspections as required.
- Manage CST scope, including out-of-scope work, overburn, invoice tracking, and KOL contracts when applicable.
- Plan and request CST resources, provide project resource updates, and train and mentor internal team members.
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