 Plan and manage clinical trials in order to achieve quality results. Provide leadership in developing study-related documents, which might include protocols, investigator files and informed consent documents  Participate in the analysis, summary and reporting of clinical data for regulatory or marketing purposes  Supervise and assess the performance of clinical team members and train team members on daily clinical operations Serve as liaisons between global study teams, investigative sites and the clinical research organization Ensure appropriate resources are available for a project and resolve project conflicts and issues as well Oversee and coordinate development and trial projects, which include developing budgets, time lines, and quality guidelines for projects, thereby ensuring that expectations are met Review invoices from study vendors, institutional review board approvals, clinical study agreements and monitoring reports Guide the selection and management of clinical research organizations used for the project study trials, and they coordinate the delivery of clinical trial supplies, as well Pro-actively work with members of the project team, identifying issues that might delay the project and making recommendations to improve time lines for project completion. This also includes compilation and driving documentation for the project, ensuring the accuracy and quality of regulatory data Overall responsible for organizing, communicating and evaluating team objectives for clinical studies to the cross functional teamCRO Management  Manage CRO for allocated study Maintain demand-supply ration Negotiate with central team for additional resourcesTraining Participate in induction program for new joinee and ongoing team trainings. Responsible for training of CRO CRAs

 Medical Writing: Preparation of Protocols, Development of ICF; Prepare Clinical Study Report, Assist in CRF design Operational: Responsible for the day-to-day cross-functional operations of the assigned Phase I & IIa projects. Ensure assigned studies are delivered successfully, on-time, within budget, according to management expectations and with the highest level of quality possible.  System & Standard Practice Development: SOPs development for Phase I Studies, Assist in development of Clinical Pharmacology Unit for Phase I Studies Training: Responsible for the team training for clinician studies Line Management: Planning, assigning, and directing work; appraising performance and guiding professional development; addressing employee relations issues and resolving problems.  Operation: Site Selection, Site Monitoring, Site Closure, Issue Resolution, Project Management & Medical Writing of Pharmacokinetic Studies (BA/BE).

 Responsible for Design and development of protocols for In Vivo studies. Involve in screening drugs for efficacy and safety and evaluation of experimental result.