FSP Operational managers manage employees within various roles seconded to client organizations (Monitoring, Project management, Data Services, Medical Affairs, Quality and Safety & Pharmacovigilance);
Ensure compliance to policies, SOPs, federal and local guidelines and GCPs;
Identify, address and follow up on performance and quality issues;
Build interactive working relationships with local client managers, to understand client satisfaction on services being provided and also potential future pipeline needs.
Participate in the interview process;
Review and approve expense reports and timesheets;
Coordinate and conduct new employee orientation and training;
Complete ISM costing tools for each resource, manage merit adjustments during anniversary cycles;
Complete weekly Ops Manager reporting on ISM;
Report to one of four European level Operational Manager Leads;
Interaction between recruitment teams, Alliance Management teams and region and/or program wide operational teams.
Supervise, coach and mentor staff;
Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring and coaching;
Set priorities and schedule activities for departmental resources in between client secondments, implement company objectives, and create alternative solutions to address business and operational challenges.
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;