Sr. Manager, MedTech Clinical Operations

Regulatory Toolkit; Washington (District of Columbia); On-site; USD 87,000 - 216,000; Full time

Job summary

IQVIA MedTech is seeking an experienced Clin Ops leader to manage a team of clinical staff supporting studies, ensuring projects are resourced and employees trained to meet objectives. They will advise senior leadership on resourcing strategies and client relationships.

The role requires strong leadership, regulatory knowledge (GCP/ICH), and the ability to oversee training plans and performance. Equal opportunity employer; base pay range provided.

Qualifications

• Bachelor's degree in scientific discipline or health care preferred.
• Experience in clinical trials with leadership is required or equivalent.
• Strong knowledge of GCP/ICH guidelines.

Responsibilities

• Manage staff according to policies and regulations; plan, assign and direct work; evaluate performance.
• Participate in hiring and onboarding of new employees and managers.
• Ensure staff have resources, training, and access to systems to perform duties.
• Allocate resources to clinical projects based on staff experience and training.
• Monitor quality of staff work and implement corrective actions as needed.
• Collaborate with cross-functional teams to meet project challenges and client expectations.

Skills

Leadership

Communication

Organization

Time management

Education

Bachelor's degree in science or health care

Tools

Microsoft Word

Excel

PowerPoint

Job description

Job Overview

IQVIA MedTech is seeking an experienced Clin Ops leader to 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. Support senior leadership on resourcing strategies and with local clients relationship.

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 (including new managers) 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.
• May mentor junior Managers
• May act as a client liaison for local sponsor affiliates.
• May mentor and coach new peers as they assimilate into this role.

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. Medical device clinical trial experience highly preferred.
• In-depth knowledge of applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Very Good solid 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.
• Ability to work under pressure with multiple internal / external clients with competing goals
• Ability in supporting the strategic decisions of the business by partnering with cross functional operational teams

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.