Senior Manager Clinical Operations

Abbott

5d • Onsite

About The Position

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. As the Senior Manager Clinical Operations you will lead and accelerate startup activities across clinical sites, reference laboratories, CROs, and other vendors. This strategic leadership role ensures timely activation, operational excellence, and quality compliance for clinical programs. The Senior Manager will collaborate closely with Regulatory Affairs, Quality Assurance, Biostatistics, and Program Management, participate in core team meetings to provide clinical insights, and drive strategic decision-making across the portfolio. Responsibilities include adherence to ICH-GCP, applicable regulatory requirements, and internal SOPs; support for regulatory submissions; continuous risk identification and mitigation; and mentorship of clinical staff while advancing scalable processes and systems.

Requirements

• Advanced degree in Life Sciences, Pharmacy, Nursing, or related field.
• 10+ years in clinical research with 5+ years in clinical operations/clinical development leadership roles.
• Demonstrated success in site/lab/CRO startup and activation across Phase I–IV (and/or device feasibility/pivotal) trials.
• Deep knowledge of ICH-GCP and applicable global regulations (e.g., FDA, EMA; ISO 14155 for device trials as applicable).
• Experience supporting regulatory submissions (IND/IDE, protocols/amendments; NDA/BLA/PMA support or equivalent).
• Strong vendor management, contract/SOW negotiation, and budget oversight skills.
• Proven risk management, problem-solving, and escalation leadership across the trial lifecycle.
• Proficiency with CTMS, EDC, eTMF and related clinical systems; strong documentation and inspection-readiness mindset.
• Exceptional communication, stakeholder management, and core team leadership skills.
• Track record of mentoring and developing high-performing clinical teams.

Nice To Haves

• Therapeutic area experience in diabetes/CGM Device-Specific Trials conducted under ISO 14155 with IDE/PMA pathways and relevant post-market surveillance requirements.
• Experience running global/multi-regional trials and navigating country-specific startup regulations.
• Direct involvement in responding to regulatory queries.
• Demonstrated implementation of risk-based monitoring (RBM) and digital acceleration for startup.
• Experience building SOPs/playbooks and leading continuous improvement initiatives.
• Professional certifications (e.g., ACRP-CP/CCRA, SOCRA CCRP, PMP).
• Travel: ~[20–30%] domestic/international for site/lab/vendor visits, audits, and key meetings.

Responsibilities

• Clinical Startup & Vendor Enablement Lead end-to-end site startup activities: feasibility, site selection, contracting, budget negotiation, regulatory greenlight, and training.
• Direct reference lab onboarding, validation/qualification, logistics, and sample/data workflows.
• Manage CRO and specialty vendor identification, RFPs, selection, contract/SOW negotiation, and ongoing performance management.
• Establish and monitor startup timelines, milestones, and drive issue resolution to meet First-Patient-In (FPI) and activation goals.
• Standardize startup toolkits (checklists, templates, risk logs, KPIs) and embed risk-based approaches (e.g., critical path, risk registers).
• Cross-Functional Leadership & Governance Contribute to core team forums, protocol design, operational feasibility, and strategic program decisions.
• Partner with Quality Assurance to ensure compliance with ICH-GCP, FDA/EMA regulations, ISO 14155 (for medical devices as applicable), and internal SOPs.
• Collaborate with Biostatistics/Data Management to ensure data integrity and readiness (EDC/CTMS/eTMF alignment).
• Coordinate with Program/Portfolio Management to align resources, budget, and critical path commitments.
• Compliance, Documentation & Inspection Readiness Ensure audit/inspection readiness for sites, labs, CROs, and sponsors; maintain eTMF health and essential document completeness.
• Oversee SOP adherence and implement CAPAs for findings or deviations.
• Contribute to clinical sections of regulatory submissions and prepare teams for regulatory queries and meetings.
• Risk Management & Continuous Improvement Proactively identify operational risks across startup and execution; maintain risk register and mitigation plans.
• Implement process improvements (RACI, playbooks, KPIs dashboards) to increase speed, quality, and reproducibility.
• Champion digital enablement (e.g., CTMS/EDC/eTMF integrations, lab portals, startup trackers) and data-driven decision-making.
• People Leadership & Mentorship Lead, mentor, and develop clinical operations staff (e.g., Clinical Trial Managers, Start-up Specialists, CRAs).
• Set clear objectives, coach performance, and foster a culture of accountability, transparency, and quality.
• Promote cross-functional learning and best-practice sharing across programs.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees