Position overview:
This role is responsible for comprehensive trial and site administration. Under the oversight of the Senior COM or COMs, 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：
Regulatory & 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
- Oversees FCPA, DPS/OFAC, and maintenance of financial systems.
You will have:
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
Experience Requirements:
- Minimum 0.5 - 2 years in Clinical Research or relevant healthcare experience
Educational Requirements:
- Bachelor's Degree (or comparable) in Business Finance/ Legal/Administration/ Life Science or equivalent Health Care related experience