Associate/Director, Clinical Operations, Medical Device & Diagnostics
Direct clinical monitoring operations for a designated Quintiles regional office or group to ensure projects are appropriately resourced and employees are trained and developed to meet project needs. Work with country/region leadership in formulating effective strategic goals and objectives for designated region and assures operational alignment with senior management priorities. Supervise Sr Clinical Research Associates (CRAs), Clinical Research Specialist (CRSs), Clinical Operations’ Managers and/or Associate Managers. Client Management for effective operational delivery.
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.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Advanced knowledge and ability to apply GCP/ICH/ ISO 13485 and applicable regulatory guidelines
Knowledge of clinical research financial parameters and project financial tracking and accounting methods
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
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in a health care or other scientific discipline or educational equivalent; 10 yrs of clinical trials experience including 3-5 years experience of medical device clinical trials. 5 years’ experience in a leadership capacity or equivalent combination of education, training and erperience.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Regular travel, approximately 30% of work week
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