Are you ready to lead complex clinical studies end to end, ensuring timelines, budgets, and study objectives are delivered with precision?
Proclinical is seeking a Project Manager to lead and coordinate clinical studies across all phases and lifecycle stages. In this role, you will work collaboratively with cross-functional teams to ensure timely delivery of study objectives while managing risks, challenges, and budgets effectively.
Responsibilities
* Provide end-to-end leadership of clinical studies in compliance with SOPs, ICH-GCP, and relevant local regulatory requirements.
* Own study level deliverables, proactively partnering with cross functional stakeholders to resolve operational risks, challenges, and execution issues.
* Ensure patient safety, data integrity, and inspection readiness through robust quality management systems and adherence to company metrics.
* Act as a primary sponsor partner, supporting delivery against study assumptions while mentoring and developing junior team members.
* Lead study set up and documentation activities, including protocol authoring and clinical study report (CSR) development.
* Conduct and oversee feasibility assessments to identify and select suitable investigational sites.
* Manage sponsors, vendors, and internal/external teams to ensure on-time, high quality trial delivery.
Key Skills and Requirements
* Degree or equivalent experience in healthcare or a relevant discipline.
* Background working as a CRA
* Strong understanding of ICH GCP, ISO 14155, and regulatory requirements.
* Ability to adapt to changing project deliverables and elevate issues as needed.
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