Clinical Trial Coordinator II

• Coordinate, oversee and complete assigned trial activities according to the task matrix
• Perform department, internal, country and investigator file reviews and document findings
• Complete allocated tasks on time, within budget and to required quality standards
• Communicate project risks to project leads and line managers
• Process documents sent to the client eTMF and perform eTMF reviews
• Distribute mass mailings and communications and provide documents and reports to internal team members
• Review and track local regulatory documents
• 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
• Assist with study-specific translations and translation quality control
• Provide technical and administrative project support
• Maintain knowledge of SOPs, client directives and applicable regulatory guidelines
• Maintain accurate trial status information in databases
• Maintain client local affiliate relationships where applicable
• Train new personnel in processes and systems
• Maintain study documentation, team lists, training requirements, system access and activity plans
• Provide system support for Activate and eTMF where applicable
• Support RBM activities, regulatory document transmission, kickoff meetings and meeting scheduling/minutes
• Coordinate with internal departments to align site start-up activities with the site activation critical path
• Assist with regulatory compliance review packages and regulatory submissions
• Obtain site-selection documents from sites
• Develop site lists and maintain investigator/site staff contact details
• Complete Site Interest Plans in CTMS and document site communications and follow-up
• Review survey data for completeness and logical consistency
• Coordinate site contact and follow-up plans and escalate concerns or non-compliance
• Gather local knowledge on site capacity and experience and support site tiering
• Conduct phone interviews with physicians and site personnel to obtain protocol-level input
• Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information
• Contribute to global strategic feasibility processes and best practices

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• At least 2 years of previous relevant experience
• Bachelor's degree preferred
• Ability to work independently or in a team
• Strong organizational skills and attention to detail
• Ability to manage multiple tasks efficiently and effectively
• Ability to analyze project-specific data and systems
• Strong customer focus
• Flexibility and adaptability to changing project timelines
• Working knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs
• Excellent English language and grammar skills and proficient local language skills as needed
• Good presentation skills
• Proficiency in MS Office (Word, Excel and PowerPoint)
• Ability to learn and master clinical trial database systems
• Ability to successfully complete the organization's clinical training program
• Effective oral and written communication skills with medical personnel
• Good negotiation skills
• Basic medical/therapeutic area and medical terminology knowledge
• Basic knowledge of local health systems
• Working knowledge of GCP and applicable SOPs
• Ability to work in a matrix environment
• Ability to manage risk and perform appropriate risk escalation
• Occasional drives to site locations and potential occasional travel

• Fully remote work mode
• Standard Monday–Friday work schedule
• Potential occasional travel
• Training and onboarding support
• Opportunity to act as a buddy during onboarding
• Participation in departmental initiatives and process improvements