Senior Manager Clinical Operations

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. Youll 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 bachelors 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. Were 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.

What Youll Work On

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.

Required Qualifications

• 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 IIV (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.

Preferred Qualifications

• 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: 2030% domestic/international for site/lab/vendor visits audits and key meetings.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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Senior Manager