Accountable for andprovides management support and direct supervision to Clinical Operations staffin the assigned area.Provides training,consultation and oversees metric compliance and quality related to operatingactivities 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 workand will review workload for all direct reports. Manages staff by establishinggoals that will increase knowledge and skill levels, and by delegating taskscommensurate with skill level.
Participate in managing the resource availability for theassigned staff / region, ensuring projects are suitably resourced and staffingneeds are identified in a timely fashion, resolving potential resourcingconflicts to facilitate mutually beneficial resolutions.
Provide expert operational oversight and guidance to supportprioritization of activities, review and monitor the work performed, metriccompliance, and development of contingency plans, among others.
Assist in recruiting new staff, including participation ininterview process and new hire on boarding. Proactively works to ensure staffretention and turnover rates remain within expected levels.
Ensures quality and adherence to Standard OperatingProcedures / Work Instructions (SOP / WIs) and compliance with federal and localguidelines and ICH GCPs.
Ensures all staff follows required training andcompletes the required documentation.Provides regular updates to management accordingly.
Works closely within appropriate business unit / region toensure staff performance on studies and correct deficiencies as identified bystaff, clients, and auditors.
Able to contribute to BU level processimprovements. May provide business development support.
May conduct various types of sign off and assessment visitsto ensure Clinical Operations on-site performance.Develop and oversee training plans to addressperformance deficiencies.
Ensures staffadheres to training guidelines, training records are maintained and individualand corporate training needs are identified and addressed.
Organizes and chairs clinical staff meetings at regularintervals. Manages issues and provides follow up for action items requiringresolution.
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%)