Responsibility：
The CTM is responsible for managing the planning, implementation, and tracking of the clinical trial process as well as risk mitigation. The CTM serves as a proactive member of the trial team, liaising closely with the Clinical Trial Leader (“CTL”) on all study-related issues. As leader of the R/OPU Trial Team, the CTM communicates trial status to stakeholders, escalating issues as appropriate.
JD:
Trial Preparation
Accountable for the trial activities for responsible R/OPU, including but not limited to:
61 Ensure the trial is conducted in compliance with GCP-ICH, local/global regulations, applicable SOPs and according to the trial protocol by overseeing CRO and internal team activities.
61 Creation, management and review of the R/OPU trial budget to ensure appropriate level of financial oversight and planning accuracy. Timely budget updates based on trial changes.
61 Appropriate trial-specific training of R/OPU internal and external partners is performed in line with Trial Training Plan.
61 Accurate planning and co-ordination of operational feasiClientlity of trial timelines for their R/OPU; and oversight of trial preparation to ensure trial team members are aligned and on track.
61 Verifies and provides input into the country and site level feasiClientlity and OPU commitment (site and patient commitment). Finalize and validate site selection using available data sources and local insights/expertise, in collaboration with other functions (i.e. Medical Affairs, vendors if applicable).
Requirement：
1：Above Bachelor degree of Pharmacy or medical related background;
2: Above 5 years clinical related experiences, including at least 1 year project management experiences in global company;
3: Good monitor and management skill