Associate/Mgr/Sr Mgr, Monitoring

Major Duties and Responsibilities:May include but is not limited too Hiring the appropriate level of employees and contract staff to meet corporate and project objectiveso Assess project resource projections and assign resources to ensure that project staffing needs are meto Implement contingency planning to accommodate project or therapeutic-specific fluctuations in workloado Develop and maintain monitoring “Best Practices”, SOPs, WPDs and templateso Participate in the evaluation and selection of CROs to provide monitoring serviceso Review and approve CVs of monitors for outsourced trials to ensure appropriate staffing by CROso Ensure that monitoring staff fulfill their responsibilities in accordance with MedImmune policies, SOPs, ICH GCPs, and applicable regulatory requirements o Collaborate with staff across functions to promote quality deliverables by MedImmune, contract and CRO monitorso Provide support to the project team as needed to ensure that monitoring for outsourced projects is managed within contractually agreed upon timelines and budgetso Identify and ensure staff compliance with functional training requirements o Ensure that monitors have proficiency in core competencieso Support development of employees to ensure optimal performance and retention of high quality employees o Support employee career development and training across multiple therapeutic areas if appropriateo Identify and implement process improvements to optimize employee and team performance o Manage compensation budget for monitoring staffo Provide strategic and operational support to study teams o Senior Manager may supervise Manager-level Requirements/Qualifications:Education: o BA/BS or equivalent experience (minimum 7 years)Experience: o Substantial clinical trials management experience as a CRA/manager in a biotech, pharmaceutical or CRO environmento Demonstrated knowledge of FDA regulations, ICH GCP and legal requirements affecting clinical trials o Complete understanding and wide application of technical principles, theories, and concepts in the field. o Experience supervising or managing professional staff in a clinical research environment o Experience with management of contract personnel and CROs is desirableo Demonstrated ability to work on complex problems where analysis of situations requires in-depth evaluation of multiple factors. o Experience with creation of infrastructure and "best practices" in concordance with core purpose o Demonstrated ability to effectively work across departments in a biotech, pharmaceutical or CRO environment with diverse and potentially conflicting needs.Special Skills/Abilities: o Excellent interpersonal and effective verbal and written communication skillso Excellent organizational and time management skills. o Ability to adapt to changing priorities. o Focuses on team interaction and cooperation rather than individual achievemento Represents the organization as the prime technical contact on contracts and projectso Chooses one's own behaviors and responses carefully based on awareness of how it impacts others and their performanceo Interacts effectively with senior individuals outside of working groupo Frequent inter-organizational and outside contactso Represents the organization in providing solutions to difficult technical issues associated with specific projectsJob Complexity: o Provide functional solutions to a wide range of difficult problems and compliance issueso Solutions are imaginative, thorough, practicable, and consistent with organizational objectiveso Contributes to the completion of specific programs and projectso Develop solutions to complex problems which require the regular use of ingenuity and creativityo Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resourceso Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives, and failure to comply with regulatory requirementsSupervision: o Works under only general direction. o Independently determines and develops approach to solutionso Work is reviewed upon completion for adequacy in meeting objectivesCLICK HERE TO APPLY MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Associate/Mgr/Sr Mgr, Monitoring Location:  US-MD-Gaithersburg Status:  Full Time, Employee Job Category:  Sales/Retail/Business Development