Head of Clinical Process and Standards

Galderma•Boston, MA

13d•Hybrid

About The Position

The Head of Clinical Process and Standards is a pivotal role in the Clinical Operations team working closely with the Clinical Operations Leadership Team. This position involves the oversight of key study components including the trial master file, clinical systems, process improvement initiatives, and clinical controlled documentation (e.g., Standard Operating Procedures (SOPs), work instructions, forms). This role will also work closely with quality to ensure inspection readiness at all times and to share best practices across study teams. This role serves as the infrastructure to ensure quality and standardization in the execution of trials, including inspection readiness, and in line with Good Clinical Practice and regulatory standards.

Requirements

Bachelor’s degree in Life Sciences or a related field, required
Minimum of 15 years progressive experience in clinical operations including 5 years in a managerial role or equivalent with Pharma/Biotech and/or CRO experience
Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP
Excellent knowledge of relevant local regulations
Excellent understanding of the product development process
Excellent understanding of Clinical Trial Management
External applicants must be eligible to work in the United States.

Nice To Haves

Systemic drug and biologics experience preferred.

Responsibilities

Lead a global team of internal/external Clinical Trial Administrators (CTAs) responsible for managing operational tasks in support of clinical trials.
Develop and implement strategies for clinical trial operations to meet organizational goals.
Oversee system maintenance and improvements for the Clinical Trial Management System and other clinical systems.
Interact with IT to determine the departmental needs and ensure timely implementation.
Ensure Trial Master File (TMF) remains inspection ready at all times, for both internally and externally managed studies.
Develop and continuously improve Galderma clinical controlled documents (i.e., SOPs, Work Instructions, Forms) to ensure high quality execution and compliance with GCP and inspection readiness.
Develop and oversee training compliance and content in the Galderma Training system (PATH).
Develop and improve study-level training tools/systems to support the study teams in training reconciliation and tracking.
Develop and implement clinical processes and tools to create consistency, enhance compliance and efficiency, while maintaining operational excellence and quality.
Develop and improve training and process materials through the identification of trends and lessons learned from study/program teams and internal/external inspections.
Serve as the BPO (Business Process Owner) for CTMS, eTMF, and other potential future clinical systems.
Establish and maintain a clinical systems roadmap aligned with portfolio growth and digital transformation objectives.
Ensure the appropriate risk and change management processes are developed and implemented to support new and updated system implementations.
Oversee eTMF system migration, updates, and inspection readiness, alongside the TMF manager.
Solicit feedback from development teams on opportunities for improvement and process optimization.
Work with members on the Clinical Operations Team to build an onboarding/training program for clinical operation roles.
Foster a culture of inspection readiness within the organization, ensuring the team aims to always maintain a state of readiness.
Serve as a conduit between clinical operations and quality to share best practices and industry and inspection trends.
Serve as member of the inspection readiness team, including regulatory inspection preparation, Corrective Actions Preventative Actions (CAPA) response drafting/review, and extrapolation of lessons learned outputs.