Country Study Start-Up Specialist I/II – Clinical Trials

CTI Clinical Trial and Consulting Services; España; Hybrid; PHP 400,000 - 800,000; Full time

Job summary

CTI Clinical Trial and Consulting Services in the Philippines is seeking a Regulatory Start-Up professional to coordinate country-level submissions, ethics committee interactions, and budget-related activities for clinical trials and real-world evidence studies.

You will support the CTI Legal team, manage site relationships, and ensure accurate documentation across TMF systems, with travel and cross-country collaboration as needed.

Qualifications

• 1-2 years of experience in Clinical Research (pharmaceutical, site or CRO service) and experience in regulatory in country.
• Associate’s or Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience.
• Fluent in spoken and written Italian and English

Responsibilities

• Informs the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country level.
• Review/prepare local submission documents and performs submissions to Ethics Committees and to Competent Authority for Clinical Trials/RWE in accordance with local country requirements.
• Identify the Central and Local Ethics Committees and Competent Authority needed for the study on the country level; process pre-payments to Ethics Committees and Competent Authority; adapts study-related documents to meet local specifications.
• Serve as applicant for Clinical trials/RWE and may act as main point-of-contact for the Ethics Committees and Competent Authority and the assigned RASSU Specialist to the study on the country level.
• Communicate closely with RASSU specialist assigned to the study regarding EC/CA outcomes.
• Accurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system.
• QC and QA of various study related Regulatory documents and reports.
• Perform review, reconciliation, close-out, and archiving activities of study or project.
• Oversee translation of regulatory documents on behalf of Sponsor, as agreed to in scope.
• Attends internal and external study meetings and regulatory status reports for each site and country during study meetings.
• Foster relationships with key contacts at each site; facilitate contract-related communication between the site and CTI; assist with site contract translation; track progress by updating internal systems; identify unique site issues; assist with site contract execution.
• Identify and establish relationship with site personnel responsible for budget proposals; interact with project management team members and clinical trials budget manager; understand site budget templates; train sites to understand budget templates; understand changes communicated by sites to budget managers; assist with translation and delivery of final negotiated budget to site personnel

Skills

Clinical Research experience

Regulatory affairs knowledge

Italian language proficiency

English language proficiency

Education

Associate’s or Bachelor’s Degree in allied health

Job description

CTI Clinical Trial and Consulting Services in the Philippines is seeking a Regulatory Start-Up professional to coordinate country-level submissions, ethics committee interactions, and budget-related activities for clinical trials and real-world evidence studies.

You will support the CTI Legal team, manage site relationships, and ensure accurate documentation across TMF systems, with travel and cross-country collaboration as needed.