Clinical Operations Manager
4 days ago
We are a leading pharmaceutical company seeking an experienced Clinical Operations Manager to oversee the successful execution of our clinical and bioanalytical studies. As a key member of our team, you will play a critical role in coordinating with internal teams, external vendors, and regulatory bodies to ensure timely completion of projects.
Key Responsibilities:- Coordinate all activities related to BA/BE and clinical studies, ensuring timely execution and compliance with protocols.
- Monitor clinical and bioanalytical phases to ensure adherence to study requirements.
- Audit CROs, manage vendor approvals, and lead negotiations on quotes.
- Identify suitable CROs, establish systems, and prepare SOPs to streamline operations.
- Handle regulatory queries and prepare departmental budgets and cost assessments.
- Prepare clinical and non-clinical overviews, including modules 2.4, 2.5, and 4, and finalize prescribing information, SmPc, and pack inserts.
- Review and finalize study protocols and reports, as well as biowaiver reports and clinical justifications.
- Review service agreements, ensuring they are active and relevant.
- Coordinate project contracts, invoices, and payments to ensure smooth financial operations.
- Manage clinical supplies for studies and represent the department in meetings, concalls, and discussions.
- Serve as the primary point of contact for external and internal communications.
- Investigate and interpret pilot study results for actionable insights.
- Work closely with cross-functional departments to ensure smooth project execution.
- $120,000 - $150,000 per annum based on experience and qualifications.
- An opportunity to work with a leading pharmaceutical company.
- A dynamic and supportive work environment.
- Professional development opportunities.
- A comprehensive benefits package.
- 16-17 years of experience in CRO management, vendor approval, and clinical project contracts.
- Expertise in handling regulatory queries and preparing clinical overviews and study reports.
- Exceptional coordination and communication skills for cross-functional collaboration.
- Ability to manage budgets and ensure compliance with SOPs.
- Adept at negotiating with vendors and ensuring timely project execution.
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