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Senior Clinical Trial Coordinator
Thermo Fisher Scientific. Provide administrative and technical support to the Project Team .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates strong organizational skills and attention to detail while coordinating project activities and supporting cross-functional teams. Proficient in managing study documentation and ensuring compliance with applicable regulations and clinical practices.
Highest-signal resume keywords
Project CoordinationRegulatory Document ReviewClinical Trial Database SystemsMS Office ProficiencyStrong Organizational Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project ManagementData AnalysisDocument ReviewProcess ImprovementTrial Master File ManagementETMF System SupportTraining and OnboardingRisk-Based MonitoringInvestigator Site File CoordinationTranslation Quality Control
Soft Skills
Interpersonal SkillsCustomer FocusFlexibilityAdaptabilityPresentation Skills
Tools & Technologies
GoBaltoETMFMS OfficeClinical Trial Database Systems
Certifications & Qualifications
PPD Clinical Training Program
Industry Keywords
ICH Good Clinical PracticesSOPsWPDsClinical TrialsProject Risks
About the role
Key responsibilities & impact- Provide administrative and technical support to the Project Team
- Coordinate and facilitate project activities and potentially serve as a study lead
- Act as a cross-functional liaison for the project team
- Support onboarding as a buddy and train new staff as needed
- Support departmental and cross-functional process improvement initiatives
- Coordinate, oversee, and complete assigned trial activities according to the task matrix
- Perform department, internal, country, and investigator file reviews and document findings
- Ensure allocated tasks are completed on time, within budget, and to quality standards
- Communicate project risks to project leads and line manager
- Maintain study documentation, team lists, training trackers, system access, and project activity plans
- Keep the electronic Trial Master File up to date and provide GoBalto and eTMF system support
- Support risk-based monitoring activities
- Process documents for the client eTMF, perform eTMF reviews, mass mailings, communications, and provide reports
- Schedule and organize client/internal meetings and complete meeting minutes
- Review and track local regulatory documents
- Transmit documents to the client and centralized IRB/IEC
- Analyze and reconcile study metrics and findings reports
- Assist with clarification and resolution of site documentation findings
- Maintain vendor trackers
- Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
- Support study-specific translation materials and translation quality control
- Attend kickoff meetings and take notes when required
Requirements
What you’ll need- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Bachelor's degree preferred
- Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 4 years
- Combination of appropriate education, training and/or directly related experience may be considered as an equivalency
- Ability to work in a team or independently
- Strong organizational skills and attention to detail
- Ability to handle multiple tasks efficiently and effectively
- Ability to analyze project-specific data/systems for accuracy and efficiency
- Strong customer focus
- Flexibility and adaptability to changing project timelines
- Working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs
- Excellent English language and grammar skills and proficient local language skills as needed
- Good presentation skills
- Excellent computer skills; proficiency in MS Office (Word, Excel, and PowerPoint)
- Ability to learn and master clinical trial database systems
- Ability to successfully complete the PPD clinical training program
- Self-motivated, positive attitude, and strong interpersonal skills
Benefits
Comp & perks- Standard Monday–Friday work schedule
- Work may be performed in an office, laboratory, clinical, and/or home office environment
- Potential occasional travel required
- Occasional drives to site locations