Clinical Trial Manager

2 weeks ago

Delhi Delhi, India Icon plc Full time

**Overview**:

- We are looking for an experienced **Clinical Trial Manager (COM)** to join our Clinical Trial Operations (CTO) team. The CTM will be accountable for the execution and oversight of local clinical trial operations and will play a critical role in ensuring regulatory, financial, and quality compliance at the country level.

**Responsibilities**:
**Key Responsibilities**
- Accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP, country regulations, and company policies.
- Ownership of country and site budgets, including contract negotiations (CTRA), financial forecasting, payment oversight, and reconciliation.
- Responsible for country submissions and approvals, including development of local language informed consents and translations.
- Ensure quality, compliance, and timely delivery of country commitments across assigned protocols.
- Collaborate with cross-functional teams (Clinical Operations, Regulatory Affairs, Medical Affairs, Finance, Legal, etc.) as well as external stakeholders (sites, vendors, IRBs, Regulatory Authorities).
- Oversee local processes including clinical supply management, archiving, insurance, and regulatory/finance system updates.
- Proactively identify risks, resolve issues, and drive process improvements to ensure protocol milestones are achieved.

**Qualifications**:
**Qualifications**
- Bachelor’s degree in Life Sciences, Business, Finance, or related field (or equivalent healthcare-related experience).
- Minimum 7 years of clinical research experience with proven expertise in clinical project management and coordination.
- Strong knowledge of local regulatory environment, submission, and approval processes.
- Experience in financial oversight, budget management, and contract negotiations.
- Excellent leadership, communication, and influencing skills.
- Ability to manage multiple deliverables across protocols in a dynamic environment.
- Fluent in English and local language.
- Demonstrated ability to drive results, collaborate effectively, and uphold the highest standards of ethics and integrity.

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