Manager, Clinical Operations

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Oversee the operational execution of all stages of clinical trials within designated therapeutic areas or specific roles.

• Allocate resources and ensure compliance with timelines, budgets, SOPs, policies, Health Care Compliance, and local regulatory requirements.

• Assist the Country Head in designing and managing the local organizational structure.

• Provide direct management for Local Trial Managers, Site Managers, Clinical Trial Assistants, and other GCO personnel.

• Supervise staff performance, development, training, project assignments, and workload distribution.

• Promote innovative solutions, process enhancements, and continuous improvement across the local and global GCO organization.

• Anticipate resource requirements and implement the One Delivery Model through vendor collaboration and oversight.

• Lead talent acquisition, human resource development, organizational changes, and communication regarding priority shifts.

• Review and authorize expenses in accordance with company policies.

• Provide coaching and mentoring to direct reports, including on-site visits when appropriate.

• Define, execute, or support long-term strategies that align with GCO, GD, and JJIM R&D strategies.

• Manage clinical trial execution and monitoring from feasibility to close-out, ensuring readiness for inspections.

• Ensure operational objectives are in line with ICH-GCP, SOPs, and other procedural documents.

• Escalate issues and report breaches in a timely and appropriate manner.

• Maintain relationships with GCO, Local Operating Company, Medical Affairs, internal departments, vendors, health authorities, ethics committees, and investigational sites.

• Develop country capabilities, oversee feasibility and site selection, and fulfill country commitments.

• Review operational and quality metrics and drive necessary follow-up actions.

⛳️ Requirements

• Bachelor's degree or equivalent required, preferably in Life Sciences.

• Minimum of 5 years of clinical research experience in the pharmaceutical industry, CRO, or investigational site.

• Proven AI literacy and an AI-enabled mindset.

• Capability to responsibly utilize AI tools in daily tasks.

• Strong communication and leadership skills.

• Ability to promote team productivity and cohesion.

• Proficient in resolving issues and developing contingency plans.

• Extensive knowledge of drug development, clinical research operations, ICH-GCP, Health Care Compliance, and applicable regulations.

• Skilled in evaluating data from various reports and sources.

• Experience in mentoring and coaching; line management experience is desirable.

• Proficient in decision-making and financial management.

• Flexible mindset with the ability to adapt in a rapidly changing environment.

• Capable of working with minimal supervision.

• Proficient in English.

• Computer literate.

• Strong interpersonal and negotiation skills.

• Excellent organizational abilities with the capacity to collaborate and manage multiple priorities in a matrix environment.

• Able to perform tasks in a timely and accurate manner.

🏝️ Benefits

• Retirement plan (pension).

• Savings plan (401(k)).

• Long-term incentive program.

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; 48 hours per calendar year for employees residing in Colorado; 56 hours per calendar year for employees residing in Washington.

• Holiday pay, including Floating Holidays – 13 days per calendar year.

• Work, Personal and Family Time – up to 40 hours per calendar year.

• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.

• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.

• Caregiver Leave – 80 hours in a 52-week rolling period.

• Volunteer Leave – 32 hours per calendar year.

• Military Spouse Time-Off – 80 hours per calendar year.

• Inclusive interview process and reasonable accommodation support.