*接受医药行业合同管理经验候选人，背景经验优秀可以接受base其他城市
1. Trial and site administration:
Track (e.g. essential documents) and report
Ensure collation and distribution of study tools and documents
2. Document management:
Prepare documents and correspondence
Collate, distribute/ship, and archive clinical documents, e.g. eTMF
Assist with eTMF reconciliation
Execute eTMF Quality Control Plan
3. Site Start-Up responsibilities: Collaborate with other country roles to:
In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
Obtain, track and update study insurance certificates
4. Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:
Develop, control, update and close-out country and site budgets (including Split site budget)
Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
Track and report contract negotiations
Update and maintain contract templates (in cooperation with Legal Department)
Calculate and execute payments (to investigators, vendors, grants)
Ensure adherence to financial and compliance procedures
Monitor and track adherence and disclosures
Maintain tracking tools
5. S/AE Claim Management:
Support Financial Clinical Operation Manager(F-COM) for:
Coordinate meetings
Update and maintain tracking tools
Develop and maintain settle agreements
Coordinate for payments
Collate, distribute/ship, and archive relevant documents
Qualifications, Skills& Experience
CORE Competency Expectations:
Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Hands on knowledge of Good Documentation Practices
Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
ICH-GCP Knowledge appropriate to role
Excellent negotiation skills for CTCs in finance area
Behavioral Competency Expectations:
Effective time management, organizational and interpersonal skills, conflict management
Effective communication with external customers (e.g. sites and investigators)
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
Demonstrates commitment to Customer focus, both internally and externally.
Able to work independently
Proactive attitude to solving problems / proposing solutions
Experience Requirements:
Minimum 1 - 2 years in Clinical Research or relevant healthcare experience
Educational Requirements:
Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience.