Job Responsibilities
- Adherence to SOPs in the planning, conducting and reporting of clinical trials. - Calculate timelines and resources for local (CTMS) use.
- Calculate study budget and prepare contracts with investigators. - Consult colleagues on country-specific issues in protocol writing.
- Produce Informed Consent for local use and the local level Investigator Site File(ISF). - Prepare investigator and site profile for investigator selection.

• Manage local clinical study progress and report to RPM for multi-national clinical trials.
• Manage local Project Teams and ensure that local standards are in harmony with agreed international standards.
• Train, counsel and guide CRAs involved in a trial on the trial requirements, procedures, monitoring standards,reporting and current issues.Records of training should be maintained.
• Contact with CTSU regarding design of country-specific labelling, packaging and drug logistics.
• Ensure timely submission to Independent Ethics Committee(IEC) and support investigator as necessary.
• Review CRA monitoring report and provide feedback as necessary.
• In conjunction with DMU, participate in regular Data Quality Review Meetings(DQRMs).
• Ensure SAEs are reported in line with GCP and SOP.

- The CTM has the final responsibility in the data clarification and correction process. - For RDC studies, ensure the completion of RDC evaluation of all sites and set RDC data in CTMS.

• Select CRO for OPU level outsourcing and complete the review of draft agreement for final approval.
• Responsible for CRA performance evaluation or provide feedback to Clinical Research Manager, if applicable.
• Organize OPU level investigator meeting.
  

Job Requirements

• Education/Degree Requirements: Bachelor's degree, higher degree/qualification, preferred (e.g. MSc, Ph D).
• Major: Life sciences or related field
• Language skills & proficiency fluent English communication
• Required capabilities (skills, experience, competencies):
• Min 3 years' experience in all aspects of clinical monitoring as a Project Manager;
• Shows good leadership qualities & excellent communication skills;
• Good organization &planning skills;
• Fluent in English; Good knowledge of GCP / Monitoring Clinical Trials /Trialmanagement;
• Achieve good quality and recruitment; All pre-requisition for CRA must be met.