What You Will Do

Responsibilities include, however not limited to:

• Act as the primary site contact and site manager for allocated clinical research sites
• Develop and maintain strong site relationships throughout all phases of the trial
• Perform site management and monitoring activities in compliance with ICH-GCP, sponsor procedures, local laws and regulations, protocol requirements, site monitoring plans, and related documents
• Develop an in-depth understanding of the study protocol and associated procedures
• Coordinate and manage site readiness activities in collaboration with other sponsor functions
• Participate in site selection and site validation activities
• Conduct remote and on-site monitoring and oversight activities to ensure data integrity and subject safety
• Conduct site visits including validation visits, initiation visits, monitoring visits, and close-out visits
• Prepare clear, comprehensive, and timely visit reports and non-visit contact reports
• Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out
• Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, audits, inspections, and site performance
• Identify, assess, and resolve site performance, quality, and compliance issues and escalate as required
• Work in partnership with internal and external stakeholders including country operations, finance, regulatory affairs, pharmacovigilance, legal, vendors, IRBs or IECs, and regulatory authorities
• Maintain information and documentation accurately in CTMS, eTMF, and other relevant systems
• Contribute to CRA team knowledge by acting as a subject matter expert, buddy, or mentor and sharing best practices
• Support and/or lead audit and inspection activities as needed
• Perform co-monitoring visits where appropriate
• Identify and develop new potential sites in line with country strategy and support the development of strong clinical research capability

What You Must have

• Associate degree, certificate, or equivalent in a scientific or healthcare discipline with relevant healthcare experience, including direct site management experience in a bio, pharma, or CRO environment, or a bachelor’s degree or above with direct site management experience in a bio, pharma, or CRO environment
• Strong understanding of clinical research, clinical trial phases, current GCP and ICH requirements, and country clinical research laws and guidelines
• Working knowledge of Global and Country or Regional Clinical Research Guidelines
• Hands-on knowledge of Good Documentation Practices
• Proven site management capability, including site performance and patient recruitment
• Demonstrated monitoring capability and independent professional judgment
• Strong IT skills, including Microsoft Office and a range of clinical applications across computer, tablet, and mobile devices
• Ability to interpret data and metrics and act appropriately
• Ability to manage complex issues in a solution-oriented manner
• Ability to perform root cause analysis and implement corrective and preventive actions
• Fluent in local language and English, with strong verbal and written communication skills
• Effective time management, organisational, interpersonal, problem-solving, and conflict management skills
• Ability to work highly independently across multiple protocols, sites, and therapy areas
• Strong accountability, urgency, and ability to manage multiple priorities in a changing environment
• Ability to work effectively in a matrix, multicultural environment
• Strong customer focus and professional demeanour
• Positive, self-driven, and growth-oriented mindset
• 
  

What You Will Do

Responsibilities include, however not limited to:

• Act as the primary site contact and site manager for allocated clinical research sites
• Develop and maintain strong site relationships throughout all phases of the trial
• Perform site management and monitoring activities in compliance with ICH-GCP, sponsor procedures, local laws and regulations, protocol requirements, site monitoring plans, and related documents
• Develop an in-depth understanding of the study protocol and associated procedures
• Coordinate and manage site readiness activities in collaboration with other sponsor functions
• Participate in site selection and site validation activities
• Conduct remote and on-site monitoring and oversight activities to ensure data integrity and subject safety
• Conduct site visits including validation visits, initiation visits, monitoring visits, and close-out visits
• Prepare clear, comprehensive, and timely visit reports and non-visit contact reports
• Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out
• Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, audits, inspections, and site performance
• Identify, assess, and resolve site performance, quality, and compliance issues and escalate as required
• Work in partnership with internal and external stakeholders including country operations, finance, regulatory affairs, pharmacovigilance, legal, vendors, IRBs or IECs, and regulatory authorities
• Maintain information and documentation accurately in CTMS, eTMF, and other relevant systems
• Contribute to CRA team knowledge by acting as a subject matter expert, buddy, or mentor and sharing best practices
• Support and/or lead audit and inspection activities as needed
• Perform co-monitoring visits where appropriate
• Identify and develop new potential sites in line with country strategy and support the development of strong clinical research capability

What You Must have

• Associate degree, certificate, or equivalent in a scientific or healthcare discipline with relevant healthcare experience, including direct site management experience in a bio, pharma, or CRO environment, or a bachelor’s degree or above with direct site management experience in a bio, pharma, or CRO environment
• Strong understanding of clinical research, clinical trial phases, current GCP and ICH requirements, and country clinical research laws and guidelines
• Working knowledge of Global and Country or Regional Clinical Research Guidelines
• Hands-on knowledge of Good Documentation Practices
• Proven site management capability, including site performance and patient recruitment
• Demonstrated monitoring capability and independent professional judgment
• Strong IT skills, including Microsoft Office and a range of clinical applications across computer, tablet, and mobile devices
• Ability to interpret data and metrics and act appropriately
• Ability to manage complex issues in a solution-oriented manner
• Ability to perform root cause analysis and implement corrective and preventive actions
• Fluent in local language and English, with strong verbal and written communication skills
• Effective time management, organisational, interpersonal, problem-solving, and conflict management skills
• Ability to work highly independently across multiple protocols, sites, and therapy areas
• Strong accountability, urgency, and ability to manage multiple priorities in a changing environment
• Ability to work effectively in a matrix, multicultural environment
• Strong customer focus and professional demeanour
• Positive, self-driven, and growth-oriented mindset
•