Clinical Project Manager

Job Title :Clinical Project Manager
Department :
Report To :
Subordinate :N/A
Sensitivity :Sensitive, NDA is a must

Project planning—Create a project team, communicate final protocol and explain scientific approach/performance to the team (e.g. cost, time, quality).
Project Monitoring and Guiding—Monitor/evaluate/review the scientific performance of the study.
Project Problem Management—Suggest solutions and actions to solve study problems, manage the impact on time and cost, review protocol changes.
Learn Process—Perform scientific mentoring activities (e.g. training study specific techniques, assisting with complex analytical work/problem solving). Participate in post project assessment by providing input on team performance (accomplishments and glitches). Responsible for the design, conduct and reporting of studies to meet scientific, regulatory requirement.
Initiate a long-range planning and technical policies of the department
Responsible for the planning and delivery of the clinical component of the project in accordance with the scope of work and timeline, and for managing the clinical portion of the study budget.
Responsible in resource allocation, task oversight and delegation, development of monitoring plans, contingency planning, and management of communications and reporting.
Lead in preparation and delivery of study documents for example SDV plan, study management plan for deliverables, confidentiality agreement and clinical trial applications.
Provide clinical monitoring expertise and leadership for large, complex protocols and/or  international programs
Lead and motivate the clinical team. Act as a mentor and train CRA in the responsibilities of the position
Promote effective teamwork among project team members
Provide performance evaluation and feedback of team members
Work independently and to effectively prioritize tasks, actively seek input, problems solve and work within a matrix team environment
Effective verbal and written communication skills. Highly effective interpersonal and organization skills. Effective presentation skills, is able to prepare a presentation for an investigators meeting.
Coordinate operational aspects of study and lead and participate in activities and ensure quality, consistency, and integration of study data and progress deliverables to time cost and quality from study concept through database lock and study close-out activities.
Provide input into non-project work, training activities, and development of procedure as needed.
Manage external service provider.
Help in the development and implementation of plans associated with audits and regulatory inspections.
Planning and conduct of investigator/monitors meetings.
Manage/coordinate the supply and reconciliation of Study Materials and Investigational product.
Demonstrate willingness to take on any level project activity consistent with current or past experience in support of study delivery.
Quality contact person of the department and in charge on the development and implementation of all SOP
Assist the staff recruitment
Assist in business development in proposal generation and undertake feasibility work.
Perform other related duties as assigned.

Job Requirements
Experience conducting clinical trials with strong knowledge of GCP/ICH-GCP guidelines
Experience making decision on the detailed execution of clinical trials
Proven clinical trial experience with more than 3 years project management
Medical life science background
Fluent English is preferred