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. Drive continuous improvement in collaboration with other managers and their respective subfamily and ensure compliance to build capability and a robust quality management to achieve customer and investigator satisfaction.

Job overview

• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
• Direct the hiring and selection process for a group of clinical staff by conducting candidate review through participation in the interviewing process. Evaluate current methods and develops office/region-based tools for onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
• 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 mentored training experiences, as applicable.
• Allocate resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training. May participate in country/region coordinated resourcing process.
• Manage the quality of assigned staff’s clinical work through regular review and evaluation of work product. This review may include review of written materials, soliciting internal and external customer feedback, and review of project assignment completion. Identifies quality risks and issues and create appropriate corrective action plans.
• Ensure that staff is meeting defined workload, quality and budget metrics through regular review and reporting of findings as outlined by clinical operations management.
• Act as a coach and mentor for staff members as they develop in their roles. Collaborate with project leadership including the PM and other functional leadership to manage project related challenges and to achieve exemplary customer service. Act as an adjunct CRS or CPM as needed to support achievement of study objectives.
• Participates in corporate or departmental quality or process improvement initiatives.

Requirements and Skills:

• B Sc degree in scientific discipline or health care
• 5 years of prior relevant experience
• In-depth knowledge of applicable clinical research regulatory requirements (i.e., Good Clinical Practice
• Knowledge of clinical research financial parameters and project financial tracking and accounting methods
• Ability to plan and meet project objectives/conflicting priorities, applying critical thinking.
• Ability to coach/mentor and develop staff in person and virtually
• Strong leadership skills
• Effective presentation skills
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
• Strong 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