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IQVIA · 1 day ago

FSP Regulatory & Start-Up - Dedicated Line Manager

Durham, NC

Full-time

Onsite

Mid, Senior Level

$86K/yr - $216K/yr

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. The role involves managing a team of clinical staff to ensure projects are resourced and employees are trained to meet project objectives.

AnalyticsHealth CareLife Science

Responsibilities

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

Qualification

Clinical trial experienceClinical research regulationsMicrosoft Office proficiencyLeadership skillsRelationship managementWritten communicationVerbal communicationOrganizational skillsProblem solving skillsTime management

Required

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