Wechat official account

 

Headquarters: Building F2, 88 Kechuang, 6th St., Beijing , China
Beijing Office : Suite 2105, Building T2, Dazu Square, Beijing , China
Shanghai Office: 595 North Caoxi Road  Building A Suite 6009 , Shanghai China
Boston Office: 99 Hayden Ave, Lexington, MA 02421, US

Tel: +86  010-56315466

Fax: +86  010-56315314

 

 

Copyright: JACOBIO PHARMACEUTICALS GROUP CO., LTD.   Beijing ICP B 17065868-1   

 

 

Post name:

Clinical PM

Salary:
Based upon experience
Work location:
Boston USA
Department:
Clinical Department
Position:
1
Job nature:
Full time
Work related experience:
5-10 years
Education:
Regular college
Post date:
2021/09/24
Page view :
Post description:

  Job description

  1.Primary interface for parent company in China and CROs to ensure the timely initiation and completion of clinical trials.

  2.Provides oversight and management of CROs, consultants and vendors•Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.

  3.Monitors the status of clinical data collection of assigned clinical trials.

  4.Performs on site co-monitoring visit to ensure the study conduct and quality according to the protocol requirement. Generates the co-monitoring report to provide issue identification and resolution advice to CRO.

  5. Engages the KOLs to discuss the compound development plan and protocol development detail. Prepares the potential investigator site lists and assists with their evaluation for inclusion in the study.

  6.Prepares and reviews study-related documents when required.

  7. Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.

  8. Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required.

  9.Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight. Requirements

Position Requirements

  1. S./M.S./Ph.D. in a scientific/healthcare field with clinical research or clinical operations experience (5+ years) within a pharmaceutical company, CRO or similar organization.

  2. Successful track record of CRO oversight or clinical project management.

  3. •Ability to work collaboratively with team members in parent company in China, as well as with external collaborators including investigators, CROs and vendors.

  4. Strong interpersonal skills and capability to influence team members to accomplish work without formal authority.

  5. Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders

  6. Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.

  7. Experienced in evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards.

  8. Strong analytical skills with a data driven approach to planning, execution and problem solving

  9. Thorough understanding of the oncology field and working knowledge of current global regulatory requirements and guidelines for clinical trials.