Principal Centralized Monitoring Analyst- Risk Manager

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Principal CM Analyst – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Principal CM Analyst, you will act as the lead subject matter expert and interdepartmental and client liaison for data analytics activities. Your area of focus may be a data analytics specialty, concentrating on the development of complex tools and processes to detect, investigate, diagnose, and mitigate issues and risks. You will engage cross-functional subject matter experts to support development or serve as a project lead, managing multiple high-volume, extremely complex projects/programs, including the setup of functional plans, tools, and delivery of review cycles. What You’ll Do: • Ensure performance of assigned reviews with high quality, on-time results with more complex analyses or deeper root cause analyses to connect related signal to risks. • Provide training and guidance to junior team members. • May participate in a project lead or development specialist role, or a combination of both. • Project leadership activities include: Independently lead the design and setup of study specific tools and centralized monitoring plan for data review; manage review timelines, develop analysis assignments for team, and support budget management; organizs, communicate with internal team, and delegate as appropriate to ensure reviews are completed on-time, on budget, with high quality; lead report development, deliver reports, and lead centralized monitoring meetings; contribute to risk assessment through the completion of the department risk assessment tools. Participate in the cross-functional risk assessment review meetings and contribute to overall risk planning. • Specialist activities include leading efforts to development of new tools and analyses within area of specialty, including complex and collaborative approaches with other functions (such as biostatistics, medical monitoring, etc.) Acts as a change agent and subject matter expert for RBQM methodology, guiding study teams in best practices. Leads and facilitates the development of study risk assessments related to data quality risks. Conducts risk assessment meetings to identify and mitigate Critical-to-Quality (CtQ) risks throughout the trial lifecycle. Reviews protocols and plans to ensure effective risk mitigation strategies and identifies gaps and overlaps. Continuously monitors study activities for risk mitigation effectiveness, reports findings to project team, and facilitates periodic risk review meetings. Develops synergistic relationship with study functional teams and clients to build productive working relationships. Education and Experience Requirements: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’). Prior experience in clinical monitoring, data management, biostatistics or related field in support of clinical trials is preferred. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Capable of applying thorough knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations • Strong attention to detail with proficient organization and multi-tasking skills • Excellent analytical /problem-solving skills /judgment in decision making • Ability to lead, motivate and coordinate teams, including coaching/mentoring team members • Demonstrated ability to maintain a high degree of confidentiality with clinical data and client's proprietary data • Sound interpersonal skills with proven flexibility and adaptability to changing situations • Strong oral and written communication skills (English) with the proven ability to communicate effectively with a variety of internal and external customers, including project team, functional management and client contacts • Strong computer skills, with strong knowledge of MS Office (Word, Excel, PowerPoint) and the ability to learn and use interactive computer systems • Demonstrated ability to extract pertinent information from standard study documentation, such as protocols, electronic study data systems and to identify trending of site/study data • Excellent knowledge and application of resource management and planning. • Knowledge of the key components of project management principles of Time, Cost, Quality • Applies a range of negotiation techniques with evidence of commercial and organizational acumen to effectively negotiate (persuade, convince, influence) and achieve desired outcomes internally and externally • Demonstrated abilty to serve as a subject matter expert and lead on projects cross-functionally, including delegating and effectively prioritzing individual and team workoad Working Conditions and Environment: • Work is performed in an office environment with exposure to electrical office equipment. • Occasional drives to site locations with occasional travel both domestic and international. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs. 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. 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.