Manager, Clinical Operations

Regulatory Toolkit; Carlsbad (CA); On-site; USD 87,000 - 216,000; Full time

Job summary

IQVIA seeks a manager to lead a clinical staff team supporting clinical studies. You will ensure resources are allocated effectively, staff are trained, and project objectives are met.

Required are a relevant bachelor’s degree, clinical trial leadership experience, and strong knowledge of GCP/ICH. The role emphasizes quality, regulatory compliance, and collaboration across clinical teams.

Qualifications

• Bachelor's degree in scientific discipline or health care preferred.
• Experience in clinical trials including management/leadership roles.
• Knowledge of GCP and ICH guidelines.

Responsibilities

• Manage staff according to policies and regulations; plan, assign, direct work; assess performance and develop staff.
• Lead onboarding and training of new employees.
• Allocate resources to clinical studies based on staff experience.
• Monitor and improve staff performance and quality of work.
• Identify quality risks and implement corrective actions.
• Collaborate with clinical teams and leadership to address challenges and ensure service quality.

Skills

Leadership

Communication

Organization

Time management

Relationship building

GCP/ICH knowledge

Education

Bachelor's degree in scientific discipline or health care

Tools

MS Word

MS Excel

PowerPoint

Job description

Job Overview

Manage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives.

Essential Functions

• Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development, rewarding and disciplining employees, and addressing employee relations issues and resolving problems.
• Participate in the selection for hiring new employees by conducting candidate review and participating in the interviewing process. Ensure that new employees are properly onboarded and trained.
• Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable.
• Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
• Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
• Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
• Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
• May collaborate with other clinical teams and other functional leadership to manage project related challenges and to achieve exemplary customer service.
• Participates in corporate or organizational departmental quality or process improvement initiatives.

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Prior clinical trial experience including experience in a management/leadership capacity or equivalent combination of education, training and experience.
• In-depth knowledge of applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good leadership skills.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of English.
• Excellent organizational and problem solving skills.
• Effective time management skills and ability to manage competing priorities.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $86,500.00 - $216,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.