Senior Manager, Clinical Operations Business Optimization

Full Time Remote in United States Operations Clinical Operations Senior Manager Apply for this Job The Senior Manager, Clinical Operations Business Optimization will partner with the Director, Clinical Operations Business Optimization to execute Clinical Operations strategic plans and projects to drive operational efficiencies across Clinical Operations and for business process optimization. They will support delivery of Clinical Operations strategic priorities 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 and training and inspection readiness activities .

Key Responsibilities Include:

• Proactively identify and address opportunities for process or business improvements including operational efficiencies
• 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 tracking and following-up on Clinical Operations staff compliance with all applicable SOPs and organization of onboarding efforts for new Clinical Operations hires.
• Contribute to budget planning and management.
• Act as a resource for the Clinical Operations team members for processes, training, and inspection readiness.
• Support enhancement of processes related to Risk Based Monitoring, central monitoring activities, protocol deviation management, risk management and TMF Review.
• Support the creation of processes for internal study management at Apellis.
• Support deployment of a systems strategy for tracking of portfolio, program, study and site level metrics, data analytics/trends.
• Maintain subject matter expertise on relevant topics such as 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.
• Provide input and support for 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.
• Support QA in 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 with plan.
• Other duties and responsibilities as required.

Education, Registration & Certification:

• B.S/B.A. degree is required. Science/health care related field and/or advanced degree preferred but not required

Experience:

• 6+ years' experience working within a pharmaceutical/biotech company, CRO, or similar organization.
• 3+ years’ experience managing clinical trials.

Skills, Knowledge & Abilities:

• Strong knowledge of applicable computer and project management software packages, including Microsoft Suite 2
• Knowledge of current regulatory requirements and guidelines governing clinical research and related terminology
• Strong strategic thinking, planning, execution, and communication skills
• Strong interpersonal skill set necessary to guide and maintain internal and external collaborator relationships and change management.
• Challenge the norm with creative solutions.
• Effectively role model the 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.
• Demonstrated ability to effectively influence and manage within a matrixed organization.

Travel Requirements:

Up to 10% domestic and/or international travel

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.