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Work Schedule Standard Office Hours (40/wk) Environmental Conditions Able to lift 40 lbs. without assistance, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Location/Division Specific Information Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies. Responsible for overall financial and operational performance of the clinical research site. This role oversees the research study management and technical operations pillars with >225 staff in the reporting structure. Establishes, implements and assesses department goal achievement while managing the day-to-day activities of the clinical and technical operations staff. Key responsibilities include logistical, operational and strategic planning for all projects being conducted at the site. Plans for appropriate study conduct and staffing logistics to ensure accountability and successful execution of Client deliverables. Attends regular standing meetings and key sponsor initiation meetings. Communicates with client representatives on a regular basis to gain feedback. Participates in meetings with company leaders to provide updates, receive feedback, discuss strategic business plans, etc. Participates in feasibility review and strategic study placement. Reviews and approves study budgets and con mods. Communicates regularly with functional area leads to discuss upcoming workload, departmental needs and performance. Participates in or leads work teams for various company initiatives, such as practical process improvement (PPI) and automation, to further the site’s competitive advantage. Supports and participates in business development opportunities such as bid defense meetings and industry conferences. Qualifications: Education and Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years) or equivalent and relevant combination of education, training, & experience. Strong background in project management, regulatory, FDA, and ICH guidelines 5+ years of management responsibility Strong leadership skills Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. Knowledge, Skills and Abilities: Extensive knowledge of clinical trials Ability to drive and adjust departmental day to day activities to effectively conduct clinical trials Excellent verbal and written communication skills Attention to detail and ability to multitask Knowledge of Microsoft Office software Strong leadership skills and critical thinking skills Excellent organizational skills Effective time management and project management skills Ability to lead and facilitate cross functional teams successfully Ability to act as a liaison with the client, investigator, study team and other departments Management Role: Directs through lower management levels. Has responsibility for managing a function that includes multiple related departments. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees. May manage employees across multiple regions. Working Conditions and Environment: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations, frequent travels both domestic and international. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
