Sr Manager, Site Start Up

hace 3 semanas


Madrid, España Precision For Medicine A tiempo completo

Due to our continued growth Precision for Medicine are hiring an experienced Manager/Senior Manager, Site Start up to join our team to line manage our team of Start up Leads in the EU/UK. Candidates can be based in Spain, Hungary, Slovakia, Serbia, Romania, Poland or UK.
Position Summary: Manages and oversees the day-to-day activities SSU personnel in accordance with Standard Operating Procedures (SOPs), regulatory directives, and study specific plans with an emphasis on effective resourcing and development of personnel. Provides oversight and leading activities for site start up project delivery; coordinates inter-departmental and client communication and helps resolve administrative, personnel, and project issues.
Essential functions of the job include but are not limited to: Develop, mentor, manage and coach SSU personnel to ensure Precision's quality standards are maintained.Advocate individual career development, and individual responsibility/accountabilityMaintain routine 1:1 meetings with SSU personnel for management of assigned tasks and career developmentMay serve as SME support for Site Start up activities.Ensure SSU personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirementsEnsure that SSU personnel have the proper resources, training, materials, and access to systems to deliver on the expectations of their positionContribute to development of training plans and hold SSU personnel accountable to achieving training goals or addressing training needsEnsure SSU personnel are in compliance with administrative tasks (i.e., time entry, corporate-level training, time/billing compliance and travel expense and expense reporting compliance, as applicable)Participate in the interview process for new SSU personnel by conducting CV review and participating in the interviewing process.Support on-boarding training for new SSU personnel in conjunction with Human Resources, Training and other functional areasContribute to development of robust standards and processes for the staff and ensure consistent, quality execution among the SSU personnelActive participant in resourcing of SSU personnel and manage FTE allocation per project to ensure time/work billed is in alignment with project budget and assumptions, with continued assessment and adjustment as neededProvides on-going feedback, development and coaching of line reports including annual performance reviewsActive participant in planning and conducting department meetings to provide routine high-level communication to SSU personnelAssists with internal initiativesPerforms other duties as assigned by managementQualifications: Minimum Required: Bachelors degree in life sciences or related field or equivalent combination of education, training, and experience.A minimum of 6 years in clinical research including extensive experience of Site Start-up working for a CRO.Demonstrated competence in people managementDemonstrated knowledge of GCP/ICH guidelines and the clinical development process.Other Required: Experience working in team environment across multiple countries with resource management experienceExperience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) and clinical software experience (CTMS, eTMF, EDC etc)Strong communication and interpersonal skills to effectively interface with others in a team settingStrong organizational skills, attention to detail, and a customer service demeanorProven experience in strategic planning, risk management and change managementFluency in English.Preferred: Advanced degree in life sciences or related fieldCompetencies Ability to work closely with business unit leadership to understand customer's needsDemonstrated analytical skills and business acumenStrong presence with the ability to confidently deliver presentations internally or for clientsHigh level of integrity and must inspire and demand the highest standards from a professional and ethical perspective.Ability to lead and inspire excellence within a teamAbility to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiencyResults oriented, accountable, motivated and flexibleProven ability to effectively influence, negotiate, and manage conflictExcellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skillsStrong presentation, verbal and written communications skillsOccasional travel may be required.#LI-NC1 #LI-Remote

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