Responsibilities include, but are not limited to:
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.