Description
We are seeking a Clinical Research Manager to oversee the execution of local operational clinical trial activities in a country operations setting. You will have ownership and impact on local regulatory and financial compliance. Your role will significantly influence the delivery of country-specific trial commitments and objectives, particularly during study start-up.
Key Responsibilities:
- Financial management: assistance with country and site budgets, delivering clinical and financial contracts within fair market value, tracking payments, and reconciliation at study close-out
- Country submissions and local language materials: responsible for country submissions and approvals, development of local language materials, including Informed Consents and translations
- Management and quality oversight: manage country deliverables, timelines, and results, contribute to local SOPs development
- Collaboration: work with internal teams, vendors, sites, IRB/IECs, and Regulatory Authorities to ensure country deliverables are met
- Local process oversight: manage clinical and ancillary supplies, importing and exporting requirements, and insurance process management
Requirements:
- University/college degree in life sciences or related field, or certification in a related allied health profession
- Relevant clinical research experience in pharmaceutical or CRO industries, or healthcare setting
- Thorough knowledge of ICH Guidelines and GCP, regulatory requirements, and drug development process
- Fluent in local office language and English, both written and verbal
Preferred Qualifications:
- Good organisational and time management skills
- Working knowledge of ICH, FDA, local regulatory requirements, and IRB/IEC guidelines
- Excellent communication skills, oral and written
- Self-motivation with the ability to work under pressure to meet deadlines
What We Offer:
- Competitive salary
- Opportunity to work with a leading clinical trial services provider