Company Description

GENOVA is a global clinical research organization that offers a wide range of clinical drug development services and innovative solutions from Phase I to IV clinical trials and HEOR. We are dedicated to enabling our partners in the pharmaceutical, biotechnology, and medical device sectors to navigate the complexities of drug development and achieve their strategic objectives in European and MEA markets. Our comprehensive services include Clinical Trials Management, Project Management, Site Management, Regulatory Support, Medical Affairs, Medical Writing, Biostatistics, Data Management, Pharmacovigilance, and Market Access Preparation. Based in the EMEA region, our focus is on delivering top-notch quality services to our clients.

Job Summary

GENOVA is a leading global CRO dedicated to accelerating drug development for our clients. We are seeking a dynamic and experienced Clinical Project Lead - Project based to oversee the planning, execution, and completion of clinical trials across various therapeutic areas. In this role, you will lead a cross-functional team and serve as the primary point of contact for our clients, ensuring that all projects are delivered on time, within budget, and to the highest quality standards.

Key Responsibilities

- Project Leadership: Lead and motivate a multidisciplinary team, including Clinical Research Associates (CRAs), data managers, biostatisticians, and medical writers, to achieve project milestones.

- Study Management: Develop, manage, and execute comprehensive project plans, including timelines, budgets, and resource allocation.

- Client Communication: Act as the main point of contact for clients, providing regular updates on project status, managing expectations, and proactively addressing any issues or risks.

- Regulatory Compliance: Ensure all trial activities comply with regulatory requirements, including ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) and relevant local regulations.

- Risk Management: Identify potential risks to the project and develop and implement mitigation strategies to keep the trial on track.

- Financial Oversight: Monitor and manage the project budget, ensuring profitability and controlling costs.

- Quality Assurance: Oversee the quality of all project deliverables, from study documents to data collection, and support internal and external audits.

Qualifications

- Bachelor's degree in a life science or a related field; an advanced degree (Master's or PhD) is a plus.

- Minimum of 4-5 years of experience in clinical research, with at least 2-3 years in a project management or leadership role within a CRO or pharmaceutical company.

- Strong knowledge of clinical trial processes, ICH-GCP, and regulatory guidelines.

- Excellent leadership, communication, and negotiation skills.

- Proven ability to manage complex projects, multiple priorities, and cross-functional teams.

- Project Management Professional (PMP) or other relevant certifications are highly desirable.

Apply now or share your CV at [email protected]

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