Clinical Research Manager
4 weeks ago
As a Clinical Research Manager at Pharmiweb, you will be responsible for overseeing the performance and compliance of assigned protocols in a country, ensuring adherence to ICH/GCP and country regulations, Fortrea's policies and procedures, quality standards, and adverse event reporting requirements. This role requires strong coordination and organizational skills, as well as expertise in budget and contract negotiations, local regulatory environments, and submission processes.
Key Responsibilities
Develop and manage country and site budgets, including Clinical Trial Research Agreements (CTRA) development, negotiation, and completion.
Oversee and track clinical research-related payments, including payment reconciliation at study close-out and maintenance of financial systems.
Execute and oversee clinical trial country submissions and approvals for assigned protocols, ensuring timely and compliant delivery of country-specific trial commitments and objectives.
Develop local language materials, including informed consents and translations, and interact with IRB/IEC and Regulatory Authority for assigned protocols.
Manage country deliverables, timelines, and results for assigned protocols, ensuring quality and compliance in assigned protocols in country.
Contribute to the development of local SOPs and coordinate with PM/CTL/CTA and CRA, Finance and Legal as necessary, to ensure country deliverables are obtained for submissions, budgets, CTRAs, and local milestones.
Provide support and oversight to local vendors as applicable and ensure local regulatory and financial compliance.
Requirements
Strong experience in clinical research or combined experience in Clinical Research and Finance/Business.
Excellent English skills and strong communication, leadership, and negotiation skills, as well as influencing and training/mentoring skills, both written and verbal, in local language and English.
Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
Education
Bachelor's Degree in Business Finance/Administration/Life Science or equivalent Health Care related experience.
At Pharmiweb, we are committed to revolutionizing the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We encourage all to apply and look forward to welcoming talented individuals to our team.
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