Job Description

Locations

• Australia, Sydney

Skills Required

• applicable Countryintermediate
• MS Officeintermediate

Required Qualifications

• Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively (experience)
• Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency (experience)
• Strong customer focus (experience)
• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines (experience)
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country (experience)
• Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non clinical/clinical aspects of project implementation, execution and closeout (experience)
• Excellent English language and grammar skills and proficient local language skills as needed (experience)
• Good presentation skills (experience)
• Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems (degree in ms office)

Responsibilities

• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system(s).
• Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
• Performs administrative tasks on assigned trials including but not limited totimely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
• Reviews and tracks local regulatory documents.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• Assists with coordination, compilation and distribution of Investigator Site File(ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study-specific translation materials and translation QC upon request.
• Assists with technical and administrative support for projects in collaboration with internal departments and team members.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
• Where applicable, develops and maintains relationship with client local affiliates.
• Champions the inclusion of Strategic Collaboration sites into the process.
• Where applicable, conducts on-site feasibility visits (Asia Pac only).
• Trains new personnel in processes and systems.
• May support the maintenance of study specific documentation and global support with specific systems, tools and trackers, including, but not limited to, study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).with completion of related meeting minutes.
• Provides support as needed to coordinate with internal departments and ensure site start-up activities within the site activation critical path are aligned.
• Assists the project team with the preparation of regulatory compliance review packages.
• May support start-up team in Regulatory submissions.
• Occasionally works directly with site(s) to obtain documents related to site selection.
• May develop site list, including research from internal and external sources to ensure the site list is reflective of the defined site profile. Ensure current investigator and site staff contact details are appropriately maintained in company systems.
• May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel. Document in real time all communication, attempts and follow up associated with site contact and survey responses.
• Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
• Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
• Ensures an efficient, effective plan is in place for site contact and follow up and ensure compliance with the plan and escalates concerns/non-compliance to management.
• May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites.
• Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information.
• Contributes to the development and roll-out of global strategic feasibility processes and best practices.
• Supports the project team in managing study finances and drives timely and accurate invoicing on site payments, vendor payments, etc.
• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system(s).
• Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
• Performs administrative tasks on assigned trials including but not limited totimely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
• Reviews and tracks local regulatory documents.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• Assists with coordination, compilation and distribution of Investigator Site File(ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study-specific translation materials and translation QC upon request.
• Assists with technical and administrative support for projects in collaboration with internal departments and team members.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
• Where applicable, develops and maintains relationship with client local affiliates.
• Champions the inclusion of Strategic Collaboration sites into the process.
• Where applicable, conducts on-site feasibility visits (Asia Pac only).
• Trains new personnel in processes and systems.
• May support the maintenance of study specific documentation and global support with specific systems, tools and trackers, including, but not limited to, study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).with completion of related meeting minutes.
• Provides support as needed to coordinate with internal departments and ensure site start-up activities within the site activation critical path are aligned.
• Assists the project team with the preparation of regulatory compliance review packages.
• May support start-up team in Regulatory submissions.
• Occasionally works directly with site(s) to obtain documents related to site selection.
• May develop site list, including research from internal and external sources to ensure the site list is reflective of the defined site profile. Ensure current investigator and site staff contact details are appropriately maintained in company systems.
• May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel. Document in real time all communication, attempts and follow up associated with site contact and survey responses.
• Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
• Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
• Ensures an efficient, effective plan is in place for site contact and follow up and ensure compliance with the plan and escalates concerns/non-compliance to management.
• May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites.
• Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information.
• Contributes to the development and roll-out of global strategic feasibility processes and best practices.
• Supports the project team in managing study finances and drives timely and accurate invoicing on site payments, vendor payments, etc.

Benefits

• general: Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.
• general: Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
• general: Flexibility: Balance your work and personal life with flexible arrangements.
• general: Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
• general: Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.
• general: Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
• general: Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
• general: Flexibility: Balance your work and personal life with flexible arrangements.
• general: Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
• general: Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.
• general: Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

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