FSP Trial Delivery Specialist
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Job Description
Senior Clinical Trial Coordinator leading project activities and supporting trial teams at Thermo Fisher Scientific. Coordinating documentation and communication for clinical projects across global teams.
Responsibilities:
- Coordinate and facilitate project activities and may serve as a study lead
- Perform department, Internal, Country and Investigator file reviews as assigned and document findings
- Ensure allocated tasks are performed on time, within budget and to a high quality standard
- Proactively communicate any risks to project leads and line manager
- Support the maintenance of study specific documentation and global support with specific systems, tools and trackers
- Ensure (e)TMF is up to date
- Provide system support
- Support RBM activities
- Perform administrative tasks on assigned trials
- Support scheduling and organization of client and/or internal meetings
- Review and track local regulatory documents
- Transmit documents to client and centralized IRB/IEC
- Analyze and reconcile study metrics and findings reports
- Maintain vendor trackers
- Assist with coordination, compilation and distribution of Investigator Site File and Pharmacy binder materials
- Assist with study-specific translation materials and translation QC upon request
- Attend Kick off meeting and take notes when required
Requirements:
- High / Secondary school diploma or equivalent
- Bachelor's degree preferred
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years)
- Ability to work in a team or independently as required
- Strong organizational skills and attention to detail
- Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Demonstrated flexibility and adaptability to reprioritize workload
- Demonstrated ability to maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for clinical aspects of project implementation
- Excellent English language and grammar skills
- Good presentation skills
- Excellent computer skills, proficient in MS Office and ability to master clinical trial database systems
- Ability to successfully complete PPD clinical training program
- Self-motivated, positive attitude with effective strong interpersonal skills
Benefits:
- Health insurance
- Retirement plans
- Flexible work arrangements
- Professional development opportunities
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