position overview
Job Location : China ( 中国 )
Job Type: Permanent Full-time ( remote)
Contract Opportunities Available
We are searching for an experienced and well-organized Clinical Trial Manager to coordinate, manage and oversee the various activities of clinical trials in China. The successful candidate should have strong clinical trial management experience and skills, have worked on international clinical studies for pharmaceutical companies and have a good understanding of GCP as per ICH requirements in addition of NMPA requirements. The candidate needs to speak and write good English to be able to communicate accurately with GRP and sponsor.
RESPONSIBILITIES
Manage and Monitor Clinical Trials
- Manage the different activities of the clinical trial.
- Ensure that all clinical trial activities are executed correctly and follow the correct protocol.
- Reports issues or problems to a Sponsor and CRO in charge of the trial.
- Ensure that the project meets the client’s goals within budget and timelines.
- Ability to manage different project team and all activities related to clinical study.
- Have the ability to prioritize tasks.
- Collaborate with sponsor and GRP management to set up tracker for all clinical trial activities and make sure they are implanted on time.
- Creates and implement study-specific clinical monitoring tools and documents
- Monitors trial budget.
- Identify, qualify and select the appropriate clinical sites.
- Coordinate and supervise clinical team (CRA, CRC, statistics, RA, Data management, monitor)
- Provides Clinical Research Associates (CRA) with project-specific training and having regular meetings with them.
- Arrange and oversees site visits.
- Assures compliance to GRP SOPs and local regulations and GCP guidelines.
- Report progress of the clinical trial and report the progress to CRO (GRP) and sponsor on regular basis
Collect Data
- Collects data from study subjects and presents it to the appropriate party (data management, sponsor, statistics).
- Collects and examine trial documents.
REQUIRED QUALIFICATIONS
- Bachelor’s degree in nursing , medical studies or life sciences.
- 5+ years work experience for pharmaceutical company or related field.
- 5 + years experience in managing clinical studies in China for international companies.
- Proficient understanding of marketing and statistics.
- Outstanding communication skills, both verbal and written in English.
- Proficient with Microsoft Office Word and Excel.
- Ability to work independently and prioritize duties.
- Understanding of Electronic Data Capture (EDC).
- Available to travel.
GENERAL REQUIREMENTS:
- Minimum Experience Level: 5 -years
- Career Level: Mid-Career
- Minimum English Level: Daily Conversation
- Minimum Mandarin Level: Native
- Minimum Education Level: Bachelor’s Degree
- Visa Status: Permission to work in China required
- Age Limit: No Age limit for applicants
INFORMATION ON GRP
- Company type: International CRO
- Company Headquarters: USA
- Office Locations : China; Shanghai and Beijing ( 上海、北京)