Clinical Operation PM
Acerand Therapeutics Ltd (China), located in Shanghai, China, is a start-up pharmaceutical company focusing on
Cancer and Autoimmune disease drug discovery research. If you have interest in this position and are determined
to make life better for people, please send your CV and contact information to firstname.lastname@example.org
Principal Duties/Responsibilities including but not limited to:
- Plans and executes trial level project management activities for assigned studies including trial level
timelines, risk assessment, mitigation plans, and other aspects of trial level project management.
- Manages the protocol execution, coordinates and maintains effective communication with sites upon request,
and ensures data compliance at the trial level to achieve country and site level compliance, as appropriate.
- Manage site relationships, project overview and provide timely inputs to ensure that trials are executed
according to agreed project plan.
- Productively identifies and communicates appropriately the status of ongoing projects, Issues, and risks
that may affect the critical path of the clinical trial and project schedule.
- Provides oversight of CRO performance throughout study implementation.
- Train, counsel and guide CRAs involved in a trial on the trial requirements, procedures, monitoring
standards, reporting and current issues. Develops study training and may also coordinate/deliver training, as
- Creates clinical trial cost forecasts. Establishes and monitors the trial budget.
- Coordinates proposal reviews with third party vendors, and provides input regarding needed changes in
Education and Experience Requirements:
- Bachelor's degree in a scientific or health related field;
- 5+ years clinical research or relevant experience, overseas project experience is highly preferred;
- Good understanding of ICH guidelines, GCP and regulatory requirements;
- Experience interacting with key functional stakeholders (clinical development, regulatory, QA, supply
chain), clinical investigators, and key opinion leaders;
- Comfortable working in a fast-paced, start-up culture with evolving processes. Flexible and able to adapt to
new situations as the business demands;
- Excellent planning, organization and problem solving abilities;
- Good communication and interpersonal skills;
- Proficiency in English and familiarity with standard IT office tools.