Ref #: 27117

Employment type: Permanent - Full-Time

Location: Malaysia

Description

RESPONSIBLITIES:

• Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
• Acts as primary local company contact for assigned sites for specific trials.
• Attends/participates in investigator meetings as needed.
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
• Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
• Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
• Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).
• May be assigned as a coach and mentor to a less experienced site manager.
• May contribute to process improvement and training.
• Leads and/or participates in special initiatives as assigned.



REQUIREMENTS:

• A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
• A minimum of 2 years of clinical trial monitoring experience is preferred.
• Must have experience in Clinical Research or equivalent qualification
• Specific therapeutic area experience may be required depending on the position.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
• Proficient in speaking and writing the country language and English.
• Good written and oral communication skills.