Senior Specialist, Site Activation
Location: Tokyo, Japan
Notice
Requisition Number: 1930
Position Title: Senior Site Activation Specialist
External Description:
SUMMARY: Senior Specialist, Site Activation is responsible for the development, dissemination, negotiation and finalization of clinical study and investigator agreements and related documents between sponsors and clinical research sites.
RESPONSIBILITIES:
Tasks may include but are not limited to
- Drafting, reviewing and analyzing site, investigator and other project-related contracts
- Negotiation and finalization or assistance in negotiation and finalization of clinical trial contracts and services contracts with WCT Legal Department, study team, Sponsors, investigators and/or clinical sites, amending and terminating such contracts
- Development and negotiation or assistance in development and negotiation of new investigators/site contracts and/or country contract templates as well as addenda to them
- Manage execution (including signature process) of contracts with sites, investigators and other project-related contracts as applicable
- Reviewing study budgets and costs pertaining to contract negotiation
- Liaising with WCT Legal Department, study teams, sponsor, sites and investigators
- Representation of the Company in relations with clinical sites, investigators, other parties and project-related vendors, as applicable
- Performing legal translation and/or proofreading of contracts with clinical sites/investigators
- Develop, monitor, track and process new and amended investigator/site contracts and other project-related contracts.
- Review contracts and other documents for completeness and accuracy.
- Maintain and update hard-copy and electronic contract files.
- Tracking system entry, maintenance and regular update as assigned
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Excellent negotiation skills and knowledge of clinical trial agreements.
- Computer literacy and confidence in working with legislation databases, document, spreadsheet and other office software
REQUIREMENTS:
- Preferable Legal background or Bachelor's Degree or equivalent in business administration, finance with the relevant experience.
- At least 3 year of experience working with investigator/site contracts.
- Experience in Clinical Research Pharmaceutical or CRO industry.
- Knowledge of ICH CGP and local country legislation in the sphere of clinical trials agreements
- Upper-intermediate English (speaking, writing).
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City:
State: Tokyo
Employment Type: Regular
Community / Marketing Title: Senior Specialist, Site Activation
Company Profile:
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
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