Manager Regulatory & Start-Up (f/m) - office-based in Uppsala, Sweden
Nr ref.: /JOBS.pl
PURPOSE This is a crucial high-profile role within Quintiles and the opportunity to progress your career in clinical research. You will manage a team and overall activities for the regulatory and start-up stage of clinical trials in the Nordics. It is a broad role which requires strong communication skills and collaboration with other functional teams in a global environment to ensure competitive cycle times and delivery of projects within the scope of work, budget and contracted timelines. As Regulatory and Start Up Manager, you will be accountable for and involved in all operational aspect of starting studies, hence solid understanding of the regulatory environment in the Nordic countries is desired. As a person you enjoy building relationships and you enjoy working cross-functionally and internationally. You are also able to dig into details when needed to improve processes and to ensure staff compliance with ICH-GCP and company SOPs. You will be responsible for development plans, coaching and performance reviews for direct reports. RESPONSIBILITIES Provide Proposal Management with input on proposals and budget development for RSU component of projects. Attend proposal defences as needed. Where applicable, review and ensure project instructions for RSU projects are complete and accurate, including local requirements as appropriate. Provide feedback to employees in the writing of project work instructions. Resource employees efficiently to ensure achievement of utilisation and realisation targets. Review and analyse performance metrics and processes to provide input in the development and implementation of process/system improvements. Support employee efficiency and adherence to standard operating procedures (SOPs), work instructions, and project instructions and timelines. Manage employees in accordance with organization's policies and applicable laws. 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 for all management / human resource matters. Mentor employee and ensure adherence to project timelines, scope of work and budget. Serve as lead for single projects or programs as necessary. Serve as advisor for designated clients as necessary. Provide RSU oversight across protocols / programmes. Serve as point of contact for issue escalation and process alignment. Participate in the selection and on-boarding process for new RSU employees by conducting candidate review and participating in the interview process. Ensure employees have the appropriate materials, systems access and training to complete job responsibilities. Support team to ensure that they successfully complete mandatory Compliance and GCP training and pass related exams.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Full knowledge of drug development process Full knowledge of applicable regulatory requirements, SOPs, and company's Corporate Standards Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines Strong knowledge of budget management and resourcing Strong working knowledge of medical terminology Strong knowledge of Microsoft Office and e-mail applications Effective communication, organizational, interpersonal, and leadership skills Strong negotiation skills Ability to independently coordinate and manage new processes Ability to lead and motivate teams Ability to handle management/personnel issues Ability to work independently and to effectively prioritize tasks Ability to work well within a matrix team environment Ability to establish and maintain effective working relationships with co-workers, managers and clients Fluent Swedish language skills and very good English language skills MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in a related field and 7 years clinical research experience; or equivalent combination of education, training and experience