Strategic Clinical Trial Operations Manager

Planet Pharma; Bridgewater Township (NJ); On-site; USD 124,000 - 138,000; Full time

Job summary

Planet Pharma seeks an experienced Clinical Trial Manager to support COL/Sr. CTM in executing clinical trial activities compliant with GCP and regulations.

The role covers regional trial oversight, cross-functional coordination, and vendor management to ensure timely, high-quality deliverables. Responsibilities include creating study documents, site feasibility assessments, and investigator engagement support, with RBQM and RBM implementation in collaboration with CROs.

Qualifications

• Minimum of 5+ years of clinical trial management experience in pharmaceutical/biotech.
• Experience in rare disease and/or orphan indications is preferred.
• Experience managing large and/or complex studies and project teams is preferred.

Responsibilities

• Supports the Clinical Operations Lead and/or Sr. CTM with management and execution of all clinical trial activities in compliance with GCP and relevant regulatory requirements.
• Detailed management and oversight of regional trial activities to ensure deliverables are met on time and within budget.
• Coordinates cross-functional study team activities to achieve high-quality deliverables through information-sharing and regular study team meetings.
• Manages regional monitoring oversight of site-level activities for ongoing and planned trials.
• Supports development of action plans addressing protocol compliance, safety, data, and administrative issues with investigator sites.
• Participates in development of study documentation (synopses, protocols, CRFs, IRB applications, recruitment materials) and liaises with CROs and legal for IRB language.
• Participates in site feasibility assessments with Clinical Development and Medical Affairs to inform site selection and enrollment targets.
• Collaborates with regional MSLs to support investigator engagement activities and may help organize investigator engagement events.
• Engages in Risk-Based Quality Management (RBQM) activities to ensure data integrity and patient safety.
• Implements RBM and centralized monitoring strategies with CROs, noting RBM not applicable for early-phase trials.
• Develops and manages detailed trial plans and may attend investigator meetings and CRO/vendor meetings as requested.
• Monitors CRO/vendor performance through metrics and milestone tracking to ensure contractual deliverables.

Skills

Clinical trial mgmt

Team leadership

CRO management

ICH/GCP knowledge

Regulatory knowledge

Self-motivation

Communication

Education

Bachelor's degree in life sciences

Job description

Planet Pharma seeks an experienced Clinical Trial Manager to support COL/Sr. CTM in executing clinical trial activities compliant with GCP and regulations.

The role covers regional trial oversight, cross-functional coordination, and vendor management to ensure timely, high-quality deliverables. Responsibilities include creating study documents, site feasibility assessments, and investigator engagement support, with RBQM and RBM implementation in collaboration with CROs.