CRA I

Career Areas Career Stories Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Careers Home Life at BMS Career Areas Student Opportunities Events How We Recruit Career Stories Search this site Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Single PositionView All JobsCRA IGuangzhou - CN No longer accepting applications.Job IDR1603934Date posted06/29/2026DepartmentNot ApplicableAct as point of contact for Sites.• Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership.• Plans, develops and executes timelines and activities for start-up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC) and other relevant stakeholders through the review and approval of essential clinical trial and regulatory documents.• Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.• Manage the end-to-end process for executing Clinical Trial Agreements (CTAgs) with investigator sites.• Prepares contract documents from templates and modify to reflect unique aspects of the particular study, including the CTAg financial appendix• Negotiates financial and legal aspects of CTAg and Master Service Agreements with sites, Institutions or vendor personnel• Prepare country Informed Consent Form (ICF) and manage country ICF template, review and approval of Site ICFs.• Review and approval of Clinical Trial Package (CTP) documentation• Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management• Update national registries as applicable• Prepare of materials for Site Initiation Visits.• Conduct support Investigator Site Assessment Visits (ISAs) and Site Initiation Visits (SIVs).• Conduct site qualification, initiation, routine monitoring and close-out visits，including post-close out across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCPPerform submission to Site Ethics Committees and Site GCP Institution, including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission). Coordinate the Site Ethics Committees and Site GCP Institution responses with study teams. • Collect and distribute of documents to and from sites including obtaining insurance certificates. • Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure theaccessibility, completeness and accuracy of data submitted by study sites.• Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA to maintain data integrity and reliability. Where required, provide training and support to site staff to uphold these standards and ensure patient safety.• Cultivate and sustain effective relationships with internal cross-functional teams and external partners, including vendors, clinical sites, and key stakeholders. Serve as the organization’s representative for clinical trials at the site level. • Motivate and influence sites to meet study objectives, including enrolment and retention goals.• Communicate...