Senior Manager, Clinical Operations Process Compliance

Full Time On-Site/Hybrid Operations Process Compliance Clinical Operations Apply for this Job The role of the Senior Manager, Clinical Operations Process Compliance is to help maintain compliance with processes, ensure regulatory compliance and promote the highest standards of quality and integrity in Clinical Operations. They will work within the Business Optimization team to help drive operational efficiencies across Clinical Operations and for business process optimization. They will support delivery of Clinical Operations activities by participating in Clinical Operations process improvement projects and supporting implementation of function-wide initiatives. In addition, they will support the Business Optimization Director with the oversight of Clinical Operations processes, training, and inspection readiness activities

Key Responsibilities Include:

• Proactively identify and address opportunities for process or business improvements including operational efficiencies
• Assist with development, revision and implementation of standard operating procedures (SOPs) and associated documents (such as work instructions and templates) for clinical trial processes to ensure compliance with applicable regulations and guidelines
• Monitoring and evaluating ongoing clinical operations activities and review of documents to identify areas of non-compliance or process inefficiencies and escalate as necessary. Maintenance and reporting of quality and compliance metrics
• Assist with resolution of quality events, deviations, audit and inspection findings. Perform trend analysis to identify areas of improvement and support implementation of corrective and preventative actions.
• Support the clinical operations team in root cause analysis and facilitating closure/evidence of completion of assigned Clinical Operations corrective action commitments; confirm that all actions and commitments related to inspections are implemented in accordance to plan and support effectiveness checks
• Support the execution of opportunities for the enhancement of core capabilities within Clinical Operations
• Support Clinical Operations initiatives (including lessons learned process) to develop innovative processes and technologies to advance operations
• Support inspection readiness activities within Clinical Operations across indications
• Maintain subject matter expertise on relevant topics such as ICH/GCP, global regulatory/industry activities, trends, and best practices
• Support innovative initiatives targeted to understand organizational needs and improve/revise clinical operations processes locally and globally
• Support training sessions on best practices, trends, regulatory requirements guidance, and GCP topics to facilitate continuous improvement in quality and on-going adherence to standards and regulations
• Up to 10% domestic and/or international travel
• Other duties and responsibilities as required

Education, Registration & Certification:

• Bachelor’s degree or equivalent in Science/Health Care related field; advanced degree preferred but not required

Experience:

• 6+ years' experience working within a pharmaceutical/biotech company, CRO, or similar organization
• Experience with Quality Assurance is preferred but not required.

Skills, Knowledge & Abilities:

• Strong knowledge and understanding of ICH/GCP/local regulations and applicability to trial(s)
• Knowledge of current regulatory requirements and guidelines governing clinical research and related terminology
• Strong strategic thinking, planning, execution, and communication skills
• Challenge the norm with creative solutions
• Ability to work in a fast-paced environment
• Ability to prioritize and manage multiple competing tasks and demands while ensuring overall quality and integrity
• Fosters open and transparent communication
• Proven ability to organize and manage multiple priorities and/or projects
• Proven time management, planning, and organizational skills required
• Proven written and verbal communication skills required
• Attention to detail and thorough follow-up skills
• Strong knowledge of applicable computer and project management software packages, including Microsoft Suite
• Ability to work successfully within a cross-functional team within an evolving organization and external vendors

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more! Visit https://apellis.com/careers/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.