Senior Clinical Trial Manager

Role Summary

The (Senior) Clinical Trial Manager (CTM) plays a key role in supporting Clinical Trial Teams (CTT) and ensuring smooth trial operations. CTMs may be assigned various tasks to support clinical trial planning, execution, and oversight of clinical trials to ensure they are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and clinical trial protocols. The CTM works cross-functionally with study teams, investigators, and vendors to ensure trial objectives are met on time and within budget. Senior Clinical Trial managers are expected to assume roles and responsibilities with more autonomy.

Responsibilities

• Develop and manage operational plans, charters, and manuals to support trial execution in compliance with regulatory and internal standards. Review of protocol and protocol amendments
• Coordinate the development of and manage updates of the Trial Oversight Plan
• Review of the Investigator's Brochure from DevOps perspective
• Review of the Clinical Trial Application submission package as well as supporting the response to Health Authority questions
• Review of Regulatory Green Light packages
• Review the Development Safety Update Report
• Develop the Global Master ICF
• Act as a key liaison between internal stakeholders and CROs to oversee sponsor oversight visits and ensure quality and compliance across all activities.

Site Selection and Management

• Collaborate with the CRO and/or internal functions to oversee site selection based on feasibility assessments, aligning site readiness with trial timelines.
• Coordinate the review of country-specific informed consent forms with internal stakeholders

Vendor Management and Oversight

• Monitor and manage vendor deliverables across trial operations, ensuring alignment with trial goals and timelines
• Participate in the selection and approval of key CRO personnel, such as Clinical Leads and trial-specific CRAs, to ensure their expertise aligns with trial demands.

Trial Execution and Monitoring

• Responsible for trial specific protocol deviation guidance and ongoing protocol deviation assessments and trend tracking
• Ensure ongoing accuracy and completeness of the eTMF, supporting inspection readiness and regulatory compliance.
• Maintain relevant sections in Clinical Trial Management Systems and Tools
• Drive the Operational Data Base review for the trial
• Engage in Risk Based Quality Management activities to enhance data quality and monitoring practices, addressing potential risks proactively.
• Responsible for maintenance of the Clinical Trial Team issue log in collaboration with Global Clinical Trial Manager
• Support GCTM in assessing key performance indicators (KPIs) at the trial level and manage escalation procedures for internal and external stakeholders.
• Participate in inspection readiness activities, support QA in audit preparations, and conduct site visits as needed.
• Oversee the tracking and reconciliation of trial-related items, such as scans and blood samples, ensuring trial data accuracy and completeness during trial closeout.

Requirements

• Bachelor's or Master's degree with relevant specialization; Master's degree preferred
• Minimum requirement: 8+ years in clinical operations
• Significant experience leading and managing clinical trials
• Experience in leading multiple complex trials, maintenance of trial documentation, CRO engagement, and budget monitoring
• Some experience managing/guiding internal (cross-functional) and external (CRO) teams

Core Skills And Competencies

• Experience working in a complex, global and matrixed organization required
• Pharmaceutical industry experience with knowledge of ICH/GCP Regulations required
• Oncology or TA specific drug development experience and various phases of development preferred
• Matrix leadership experience (ability to lead without authority) preferred
• Experience mentoring others required
• Developing skills in project management and knowledge of tools and processes
• End-to-end trial planning and execution knowledge proficient
• Regulatory submissions, metric development and monitoring knowledge
• Strong written and verbal communication, negotiation, collaboration and interpersonal skills
• Ability to lead and collaborate with cross-functional teams
• Strong trial planning and budget management skills
• Strong understanding of clinical trial processes, ICH-GCP regulations, and the clinical drug development lifecycle
• Proficient in outsourcing and vendor management
• Experience managing trials in global settings and multi-regional operations

Education

• Not specified beyond degrees listed in Requirements

Additional Requirements

• This role is hybrid and requires 60% in the office.