Thermo Fisher Scientific
Centralized Monitoring/Risk Manager
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Join Us as a Risk/Centralized Monitoring Manager – Make an Impact at the Forefront of Innovation
Locations: UK/Poland/open to all EMEA locations
Employment Type: Permanent
Remote/Hybrid available
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; organiz, 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.
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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 ability to serve as a subject matter expert and lead on projects cross-functionally, including delegating and effectively prioritizing individual and team workload
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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.
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