Clinical Quality Management (Cqm), Principal Manager - Home-Based

Project Management & Execution

• Manages and drives all aspects of document development, revision, retirement, according to the Procedure section of this Charter, ensuring documents are written in alignment with sponsor procedures and quality standards.
• Supports Document Owner with authoring. May author new documents upon request and as appropriate.
• Ensures Document Owner is informed of the process to develop, revise, or retire a controlled document.
• Leads and drives Implementation planning in close collaboration with Document Owner and other relevant stakeholders.
• Ensures final endorsement of document(s) prior to coordinating approval workflows in the Document Management System (DMS).
• Manages and drives collaborative review, ensuring relevant functional area representation and drives resolution of edits/comments in collaboration with relevant stakeholders.
• Ensures completion of Learning Needs Assessment and Training Curriculum Impact Assessment.
• Acts as QMS Action Item Owner for CAPA Action Items requiring a controlled document revision.
• Acts as QMS Planned Deviation Owner for Planned Deviations identified as part of implementation planning.

• Exemplary QC skills
• Strong operational understanding of Clinical Trials and GCP
• It is essential that this person wants to use their knowledge and experience to improve the way Global Clinical Operations (GCO) runs clinical trials. This person will be leading meetings and facilitating conversations and completion of deliverables with Subject Matter Experts.
• Project Management experience is a must
• Bachelor’s degree in a life sciences discipline highly preferred
• Sponsor/CRO GCP experience required (experience in a Clinical Project Manager role is ideal)
• Typically requires 8-10 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industry
• Exemplary organization, communication, and facilitation skills
• Strong interest and understanding of Process/Controlled Document Management – this can be trained for the right person