This role is responsible for comprehensive trial and site administration. Under the oversight of the Senior COM or COMs or CTC Manager, the person prepares, collates, distributes and archives clinical documents.

The role is critical to meet planned Site Ready dates. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.

Responsibilities include, but are not limited to:
· Document management:
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eTMF
- Assist with eTMF reconciliation
- ｕｐｄａｔｅ manuals/documents
- Obtain translations of documents

· Site Start-Up responsibilities:
Collaborate with other ｃｏｕｎｔry roles to:
- Obtain, track and ｕｐｄａｔｅ study insurance certificates

· 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
- Obtain and process FCPA documentation in a timely manner

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

Behavioural 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
· Positive mindset, growth mindset, capable of working independently with assigned tasks
· Contributes to CTC team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required


Educational Requirements:
· Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience.

專業要求：不限