HUTCHMED

Career Opportunities

Hutchmed
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Job Title:	CRA Line Manager (AD)
Job Title:	Clinical Operation
Location:	Beijing

Responsibilities

Be responsible for CRA team management and operational management system.
Oversees the performance of the CRAs within their specified team. Implements professional development and performance evaluations;
Ensures that clinical monitoring activities of their assigned team are performed to the project’s satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements;
Supports the training and development of clinical monitoring personnel within their remit and ensures team members’ consistent use of study tools and training materials;
Tracks clinical monitoring metrics such number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required trainings;
Performs on-site Accompanied Site Visits with CRAs;
 Identifies quality issues related to clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, Accompanied Site Visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions;
Serves as a point of contact for CRAs and other team members for assigned projects or initiatives;
Assists with assessing and interviewing potential clinical monitoring candidates;
May conduct on-site monitoring visits to offer support to project teams;
May perform site visit report review and track site visit report metrics to ensure compliance;
May review and provide feedback on related SOPs and TOOLs during updates;
Serves as a management contact for sites, project teams, and sponsors when issues related to clinical monitoring and trial management activities must be escalated to ensure communication is maintained and resolution is achieved.

Qualifications

Education:

- Sc. in a field relevant to clinical research

Experience:

- Minimum of 10 years of experience in clinical research in the biotechnology, pharmaceutical, or CRO industry

Knowledge and skills:
- Excellent oral and written English skills.
- Excellent line management skills
- Strong knowledge of ICH/GCP standards and applicable regulatory requirements;
- Quick learner, good adaptability and versatile;
- Excellent leadership, judgement and problem-solving skills;
- Strong organizational, communication, time management and multi-tasking skills;

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Job Title:	Clinical Project Manager
Location:	Shanghai / Beijing / Guangzhou / Nanjing / Hangzhou / Suzhou / Tianjin

Primary Function

Management of clinical research project.
Vendor (CRO, Lab, drug storage, etc.) supervision and management.
Liaison with KOLs.
Support IND and NDA filing.
Quality control of the clinical research projects, such as co-monitoring.

Responsibilities

Adhere to corporate SOPs and local WIs in the planning, conduct and reporting of clinical trials.
Provide leadership in the conduct of clinical trials, protocol implementation, data analysis, management of project progress and timelines.
Input operational part of the protocol for trials.
Review and approve study CRFs.
Prepare Monitoring Manual and ensure it is in agreement with the protocol and SOP.
Contact with CMC department regarding design of labeling, packaging and drug logistics.
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.
Select clinical trial site and keep good relationship with investigators.
Initiate and ensure timely submission to IRB/IEC and support investigator as necessary.
Support contract negotiation with study sites.
Select and cooperate with statistician to conduct data analysis when required.
Participate in regular Data Quality Review Meetings.
Coordinate final trial report.
Support CRO Selection.
CRO supervision at the trial level.
Support IND and NDA filing: Document review and progress tracking.
Do co-monitoring visits for the project.
Review monitoring reports.
Check TMF before archiving.

Qualifications

At least bachelor degree in pharmacy, biochemistry or related major. Mater degree is preferred.
At least 3 years industry experience with proven proficiency in clinical research management for drug development.
Good understanding of ICH guidelines, GCP and regulatory requirements.
Excellent planning, organization and problem solving abilities.
Good communication and interpersonal skills.
Proficiency in English and familiarity with standard IT office tools.

If interested, please forward your resume to winniew@hutch-med.com

Job Title:	Medical Science Liaison
Location:	Beijing / Nanjing

Position Overview & Key Results Areas

The Medical Science Liaison serves as an advocate for company science within the healthcare community. By virtue of his/her training, the MSL is well-positioned to discuss and provide scientific and therapeutic information to Health Care Professionals and Researchers (Clinical and Scientific Leaders) viewed by their peers to be authorities in a therapeutic field. The MSL is responsible for ensuring that he/she is fully versed in the therapeutic area and up-to-date on all major studies, both ongoing and completed, competitive product information and clinical data.

Develop an understanding of regional and national scientific leaders and the healthcare environments in which they work through effective professional engagement with scientific leaders that are centered on science and credible exchange of unbiased scientific information.

Interact with managed care organizations, healthcare professionals, clinical investigators, and other healthcare organizations providing fair, balanced, and scientifically rigorous medical and clinical information.
Meet with healthcare professionals who might be interested in engaging in a scientific discussion regarding a product’s medical and clinical profile in the context of approved prescribing information as well as in response to unsolicited questions or requests for information which may involve off-label information. (Unsolicited means that the information request was neither suggested nor encouraged by the MSL or sales representatives)
Participate in the development and implement tactics identified in the Medical Affairs Plans (MAP).
Work with clinical research personnel to identify potential investigators clinical research projects, based on the investigator's expertise and access to appropriate patients.
Alert investigators to company program for Investigator Initiated Study Proposals, working together with the medical manager on the process for submitting investigator designed proposals for review and approval; encourage and facilitate research publication of investigator initiated studies, in strict compliance with company policy and local country regulations.
When requested (and consistent with local SOPs), may represent the Medical Department at Local or Regional Medical events (e.g. Medical Congresses and Symposia.)
Facilitate the submission and publication of the study result from investigator initiated or company initiated projects.

Candidates to possess a master degree in the life sciences (MD, Pharm.D, or Pharmacist, Biology) preferably with a specialization in the experience of Oncology.
Requires strong scientific baseline knowledge in therapeutic area, clinical trials methods, implementation and interpretation, sound scientific and clinical judgment, and eagerness to learn more in depth in therapeutic area.
Strong, confident and engaging presentation skill, and capable for customer facing.
Outstanding communication and skills and the ability to function within a team environment.
Proactive