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.