Senior Clinical Project Manager

We are seeking an experienced Clinical Project Manager to oversee and coordinate clinical activities in pharmaceutical environment.

The role involves managing operational aspects of clinical trials, ensuring compliance with regulatory.

Requisitos

, and acting as the primary interface between local stakeholders, investigators, vendors, and global teams.This position requires strong autonomy, rigor, and excellent communication

Habilidades

, with the ability to navigate cross‑functional environments.Key

Responsabilidades

: 1

Study ManagementLead and coordinate clinical trial activities at the local level from start‑up to close‑out.

• Ensure local execution of global study plans in alignment with timelines and quality standards.

Serve as the key point of contact for local investigational sites and regional stakeholders.

Regulatory & Compliance OversightEnsure that clinical trial activities comply with local regulations, ICH‑GCP, and internal SOPs.

Coordinate local submissions to competent authorities and ethics committees when required.

Monitor adherence to regulatory timelines and manage any corrective actions.

Site & Vendor CoordinationSupport site selection, activation, monitoring, and close‑out in collaboration with CRAs and vendors.

• Manage relationships with local vendors (logistics, labs, CRO partners).
• Follow up on recruitment progress, performance, and site‑level metrics.

Cross‑Functional CollaborationWork closely with global study teams, medical affairs, regulatory affairs, and clinical operations.

Participate in study meetings and provide updates on local activities, challenges, and achievements.

• Support risk mitigation plans and operational troubleshooting.

Data Quality & Operational TrackingOversee data accuracy, query resolution, and compliance of documentation.

Track KPIs, patient recruitment, timelines, and operational deliverables.

Contribute to audit and inspection readiness.

RequirementsExperienced in Clinical Operations within pharma or CRO.

Experience as.