JOB DESCRIPTION:
Primary Function
Provides global or regional leadership for a particular regional or global clinical program. Ensures design and execution of high quality clinical studies to ensure safety and effectiveness of the company’s products. Manages clinical project team members to appropriate and timely completion of projects; oversees project timeline development and maintenance. Internally interfaces with data management and biostatistics, clinical research associates, medical directors, functional management, and acts as a company liaison with investigators and clinical site staff. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Major Responsibilities
- Responsible and accountable for several concurrent clinical studies for multiple programs and therapeutic areas.
- Leverages resources, expertise, and knowledge across projects to ensure deliverable attainment. Develops staffing plans to appropriate align resources to workloads.
- Hires, trains, develop, mentors, and supervise managers and clinical staff. Develops staffing plans.
- Participates in and assists in the development of global clinical strategies for assigned therapeutic area(s) working in collaboration with regulatory affairs, marketing, research & development, reimbursement and outcomes planning, and regions to obtain approvals by the most effective method possible.
- Supports regulatory/clinical strategies as the clinical representative for the therapeutic area or region.
- Oversees the preparation and management of budgets for projects in therapeutic area.
- Negotiates contracts and budgets with sites and vendors.
- Reviews and approves protocols for projects; reviews final study conduct documents such as study manuals, study tools, etc.
- Drafts, reviews, and approves instructions for use for investigational devices.
- Attends investigator and coordinator meetings, representing the region.
- Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
- Provides advice on the reportability of adverse events and other clinical trial issues to regulatory agencies.
- Determines membership criteria and identifies potential members for clinical events committees and data monitoring committees. Reviews and approves trigger plans for Clinical Event Committee and Data Monitoring Committee.
- Manages data release and review meetings for projects in therapeutic area; reviews and participates in finalizing and approving final manuscript or final reports for projects.
- Participates in the dissemination of clinical information to the clinical team members and extended core team members, as appropriate.
- Reviews and approves corrective action plans at individual sites and across study. May participate in internal/external study-related audits.
- Develops and maintains Clinical Affairs infrastructure such as the drafting and/or reviewing of Divisional Work Instructions and local Instructions.
- Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable company’s SOPs and policies.
Minimum Requirements
Education:
Bachelor’s degree or equivalent
Background:
- 10+ years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials。
Preferred Requirement
- 5+ years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting.
- Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred.
- PhD-level degree (or equivalent), or qualification in medicine preferred.
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Clinical Affairs / Statistics
DIVISION:
MD Medical Devices
LOCATION:
Japan > Tokyo : Hamarikyu Park Side Place 9F, 17F 5-6-10,Tsukiji,Chuo-ku
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 25 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Not Applicable