Site Contracts Specialist, FSP, Malaysia
This role administers and negotiates site contracts that support projects within Clinical Operations on a global scale. Ensures site contract documentation is in compliance with sponsor and company requirements. Identifies project and/or individual site contract related problems and works with internal and external team members to provide and implement solutions.
About the Role
We are seeking an experienced Site Contracts Specialist to join our team. As a Site Contracts Specialist, you will be responsible for administering and negotiating site contracts that support projects within Clinical Operations on a global scale. You will ensure site contract documentation is in compliance with sponsor and company requirements, identify project and/or individual site contract related problems, and work with internal and external team members to provide and implement solutions.
Your Key Responsibilities
- Administer all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
- May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
- Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template. Provide support in submissions for proposed contract and budget for site.
- Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
- Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
- Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
Your Skills and Qualifications
To be successful in this role, you will need:
- A BA/BS degree in Business Administration, Public Administration, Public Health, or a related field, or equivalent combination of education and experience. Advanced degree preferred.
- High level of contracts management experience.
- Experience in a contract research organization or pharmaceutical industry essential.
- Strong knowledge of the clinical development process and legal and contracting parameters.
- Strong computer skills in Microsoft Office Suite.
- Customer focused and ability to manage challenging priorities and to remain flexible and adaptable in stressful situations.
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
- Good understanding clinical protocols and associated study specifications.
- Excellent understanding of clinical trial start-up processes.
- Project management experience in a fast-paced environment.
- Good vendor management skills.
- Excellent written/oral communication, presentation, documentation, interpersonal skills as well as strong team-orientation.
- Strong organizational skills with proven ability to handle multiple projects excellent communication.
- Quality-driven in all managed activities. Strong negotiating skills. Strong problem-solving skills.
- Ability to mentor, lead and motivate more junior staff.
What We Offer
We offer a range of benefits, including:
- Competitive salary and bonus scheme
- Comprehensive health insurance package
- Retirement plan
- Paid time off and holidays
- Professional development opportunities
- Collaborative and dynamic work environment