Accountable for and provides management support and direct supervision to Clinical Operations staff in the assigned area.Provides training, consultation and oversees metric compliance and quality related to operating activities of assigned staff to ensure project deliverables are met.
·Line management of Clinical Operations staff, responsibilities including administrative oversight, professional development, performance appraisals, and employee counselling for staff.May be involved in assignment of project work and will review workload for all direct reports. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
·Participate in managing the resource availability for the assigned staff/region, ensuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions.
·Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others.
·Assist in recruiting new staff, including participation in interview process and new hire on boarding. Proactively works to ensure staff retention and turnover rates remain within expected levels.
·Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCPs. Ensures all staff follows required training and completes the required documentation.Provides regular updates to management accordingly.
·Works closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, clients, and auditors. Able to contribute to BU level process improvements. May provide business development support.
·May conduct various types of sign off and assessment visits to ensure Clinical Operations on-site performance.Develop and oversee training plans to address performance deficiencies.Ensures staff adheres to training guidelines, training records are maintained and individual and corporate training needs are identified and addressed.
·Organizes and chairs clinical staff meetings at regular intervals. Manages issues and provides follow up for action items requiring resolution.
Bachelor’s degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership capacity or equivalent combination of education, training and experience is required.
Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirement
Excellent communication, presentation, interpersonal, and change management skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Strong time management, technical and organizational skills. Ability to work independently and within a team environment.
Knowledge of basic financial concepts as related to forecasting and budgeting. Understands project budgets.
Must demonstrate good computer skills and be able to embrace new technologies
Ability to travel as necessary (up to 25%)
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
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