Clinical Compliance Manager

About the Role:

Independently leads and collaborates with Clinical Operations (ClinOps) to drive strategic initiatives related to clinical process compliance, continuous improvement, and inspection readiness. Plays a pivotal role in shaping and implementing process enhancements, including study-specific training programs and management of NBI consent document templates. Oversees the facilitation of training and the creation and revision of controlled documents to ensure operational excellence. Serves as a key ClinOps liaison, adept at identifying procedural gaps and championing innovative solutions to enhance efficiency and effectiveness across clinical processes.

Your Contributions (Include, But Are Not Limited To):

• Guides study teams on audit/inspection activities, offering insights on findings, and escalating issues to Clinical Compliance (CC) Director when necessary
• Serves as the ClinOps point person, providing key advice on clinical processes and Good Clinical Practices (GCP)
• Develops and reviews new or updated ClinOps controlled documents, coordinate input from Subject Matter Experts (SMEs), assess impact, propose implementation plans, and manage timelines
• Leads process integration and collaboration with vendors (e.g., CROs)
• Oversees the management and updating of NBI consent document templates and related documents
• Collaborates with NBI Drug Safety and Pharmacovigilance (DSPV) to ensure compound risk language is accurately included in consent documents
• Manages and oversees Study-Specific Training (SST) activities, such as maintenance SST matrix templates, processing of document submissions for SST assignments, and compliance with SST processes
• Manages SST system solution implementation, updates and user access.
• Manages ClinOps training activities, including developing training materials and conducting live training sessions under guidance from CC Director
• Oversees the distribution lists (DL) management process (e.g., ensure DLs for internal distribution of safety reports are created and all applicable study team members are listed prior to the first study participant is screened)
• Oversees ClinOps training curriculum reviews, making sure controlled documents are assigned appropriately for training based on roles and consulting with group leads when necessary
• Participates and promotes collaboration in departmental and cross-departmental meetings, as necessary
• Develops and maintains working relationships with other functional areas outside of Clinical Operations
• Demonstrates knowledge of applicable regulatory requirements, and business standards
• Constantly maintains knowledge in an on-going manner
• Performs other duties as assigned

Requirements:

• BS/BA degree in life science or related field AND 6+ years of experience in Clinical Compliance, Clinical Operations, or related areas within the biopharmaceutical industry. Previous experience as a Clinical Trial Associate (CRA), Clinical Trial Manager (CTM) or Clinical Research Coordinator, or equivalent, preferred OR
• Master's degree life science or related field AND 4+ years of similar experience noted above
• Proven expertise in audit/inspection-related activities, Good Clinical Practices (GCP), and regulatory compliance, and inspection readiness
• Strong leadership and collaboration skills, with a track record of effectively leading and supporting cross-functional teams
• Excellent communication and interpersonal skills, with the ability to work effectively with internal and external stakeholders
• Extensive experience in maintaining controlled documents, managing training activities, and coordinating cross-departmental collaboration
• Comprehensive understanding of regulatory requirements and standards in the biopharmaceutical industry, with a commitment to ongoing learning and professional development
• Excellent organizational skills and be detail oriented
• Proficiency in both collaborative and independent work, with the capability to mentor and lead junior team members
• Comprehensive project management expertise, including resource allocation, timeline governance, and risk mitigation strategies
• Excellent computer skills. Experience with Veeva Vault preferred
• Working knowledge of Clinical Operations, specifically conducting clinical studies from start-up through close-out
• Advanced problem-solving and analytical thinking skills
• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency