6 дней назад
Clinical Operations Manager - Regulatory
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Operations Manager - Regulatory (Clinical Trials): Managing country-level regulatory submissions, approvals, budgets, contracts, and site readiness for assigned clinical trial protocols in Uganda with an accent on ICH/GCP compliance, financial oversight, and local regulatory coordination. Focus on coordinating country deliverables, interacting with IRBs/IECs and regulatory authorities, overseeing vendors and supplies, and maintaining clinical and financial compliance.
Location: Uganda
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Own country and site budgets, negotiate Clinical Trial Research Agreements, and oversee clinical research-related payments and reconciliation.
- Execute and oversee country-level clinical trial submissions, approvals, regulatory interactions, and site readiness for assigned protocols.
- Manage country deliverables, timelines, milestones, quality, compliance, and financial commitments.
- Coordinate with project managers, CTAs, CRAs, headquarters, country operations, finance, regulatory affairs, legal, vendors, sites, IRBs/IECs, and regulatory authorities.
- Oversee local processes for clinical supplies, importing and exporting, destruction, filing, archiving, retention, insurance, and clinical and finance system updates.
- Support process improvement, contribute to SOP development, provide training, and share expertise as a subject matter expert or mentor.
Requirements
- Experience managing country-level clinical trial operations, regulatory submissions, approvals, and site start-up activities.
- Knowledge of ICH/GCP, country regulations, sponsor procedures, quality standards, and adverse event reporting requirements.
- Ability to manage budgets, financial compliance, contracts, payments, and agreed timelines.
- Ability to develop local-language informed consents and other regulatory materials and interact with IRBs/IECs and regulatory authorities.
- Ability to coordinate internal stakeholders, external partners, vendors, investigators, and clinical trial sites.
Culture & Benefits
- Work in a global clinical research and healthcare intelligence organization.
- Collaborate across country operations, regional functions, headquarters, vendors, sites, and regulatory stakeholders.
- Contribute to continuous improvement initiatives, best-practice sharing, training, and mentoring.
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