Senior Clinical Trial Manager-INFL

3 weeks ago

Beijing, China Boehringer Ingelheim Full time

About Human Pharmaceutical Business 
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
 

Job Responsibilities
- Adherence to SOPs in the planning, conducting and reporting of clinical trials.
- Calculate timelines and resources for local (CTMS) use.
- Calculate study budget and prepare contracts with investigators.
- Consult colleagues on country-specific issues in protocol writing.
- Produce Informed Consent for local use and the local level Investigator Site File (ISF).
- Prepare investigator and site profile for investigator selection.
- Manage local clinical study progress and report to RPM for multi-national clinical trials.
- Manage local Project Teams and ensure that local standards are in harmony with agreed international standards.
- Train, counsel and guide CRAs involved in a trial on the trial requirements, procedures, monitoring standards, reporting and current issues. Records of training should be maintained.
- Contact with CTSU regarding design of country-specific labelling, packaging and drug logistics.
- Ensure timely submission to Independent Ethics Committee (IEC) and support investigator as necessary.
- Review CRA monitoring report and provide feedback as necessary.
- In conjunction with DMU, participate in regular Data Quality Review Meetings (DQRMs).
- Ensure SAEs are reported in line with GCP and SOP.
- The CTM has the final responsibility in the data clarification and correction process.
- For RDC studies, ensure the completion of RDC evaluation of all sites and set RDC data in CTMS.
- Select CRO for OPU level outsourcing and complete the review of draft agreement for final approval.
- Responsible for CRA performance evaluation or provide feedback to Clinical Research Manager, if applicable.
- Organize OPU level investigator meeting.
 

Qualifications
- Education/Degree Requirements: Bachelor’s degree, higher degree/qualification preferred (. MSc, PhD).
- Major: Life sciences or related field
- Language skills & proficiency fluent English communication
- Required capabilities (skills, experience, competencies): Min 3 years’ experience in all aspects of clinical monitoring as a Project Manager;Shows good leadership qualities & excellent communication skills;Good organization & planning skills;Fluent in English;Good knowledge of GCP / Monitoring Clinical Trials / Trial management;Achieve good quality and recruitment;All pre-requisition for CRA must be met

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