Clinical Trial Coordinator (CTC)

Responsibilities include, but are not limited to: Principal:

• Budgeting, Agreement and Payments:

Collaborate with finance/budgeting representatives for: o Develop, control, update and close-out country and site budgets (including Split site budget) o Develop, negotiate, approve and maintain contracts (e.g. CTRAs) o Track and report contract negotiations o Update and maintain contract templates (in cooperation with Legal Department) o Calculate and execute payments (to investigators, vendors, grants) o Ensure adherence to financial and compliance procedures o Monitor and track adherence and disclosures o Maintain tracking tools o Obtain and process FCPA documentation in a timely manner

Desirable:

• Trial and site administration:

o Track (e.g. essential documents) and report (e.g. Safety Reports) o Ensure collation and distribution of study tools and documents o Update clinical trial databases (CTMS) and trackers o Clinical supply & non-clinical supply management, in collaboration with other country roles o Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)

• 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
• 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

• Completed job training (office management, administration, finance, health care preferred) or Bachelor's Degree

Required Skills:

Accountability, Accountability, Analytical Problem Solving, Audit Trails, Budget Development, Clinical Data Management, Clinical IT, Clinical Research, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trials Monitoring, Clinical Trials Operations, Clinical Trial Support, Compliance Reporting, Conflict Management, Contract Processing, Customer Centricity, Data Analysis, Decision Making, Documentation Preparation, Document Management, Drug Regulatory Affairs, Growth Mindset, ICH GCP Guidelines {+ 9 more}