Regulatory and Start Up Dedicated Line Manager (FSP)

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 in scientific discipline or health care preferred.
• 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.