Senior Clinical Research Associate, APAC

Provides support in start up, enrollment, follow up and closure of clinical trial activities. Develop and execute monitoring plans through protocol analysis for remote risk management. Continually monitor data and analyze findings to decide whether to conduct a remote or targeted on-site monitoring visit. Prepare for and conduct regular Site Compliance Meetings, reviewing Key Risk Indicator and any associated action items. Oversee monitors and ensure adherence to service level agreements as well as legal and regulatory standards. Collaboration: participates in study-specific meetings, teleconferences and trainings. Conduct regular meetings with monitor team. Collaborates with cross-functional team members and study sites throughout all study phases. Collaborate with clinical KOLs and internal teams to manage clinical strategy and support audit response. Source Verification: conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records. Issue, investigate and resolve data discrepancies. Communications: ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence. Training: ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitor and maintain site personnel list, qualification and training records. Site Compliance: ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. Support regulatory inspection activities as required. Event Reporting: ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations. Documentation: Manages study contracts, request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in applicable database. Performs budget negotiations. Bachelor's degree or equivalent required, preferably in life sciences, medicine, or a related discipline. Requires at least 5 years of site management experience or equivalent experience in clinical research, with an understanding of clinical trial methodology and terminology. In‑depth knowledge of, and skill in applying, applicable clinical research regulatory requirements (e.g., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and ISO 14155). Strong interpersonal, verbal, and written communication skills, including good command of the English language. Expertise in site management and data integrity, with proficiency in relevant clinical trial software and tools. Ability to establish and maintain effective working relationships with cross‑functional teams and stakeholders. Able to initiate and maintain work schedules and priorities Strong organizational and problem‑solving skills. Able to independently determine and develop approaches to solutions. Assists in establishing departmental policies and procedures Ability to work across cultures and to mentor less experienced staff by setting an example, providing guidance, and offering counsel. Able to accommodate extensive travel requirements according to task allocation and the status of assigned studies.