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 2700 clinical trials across 100 countries in the last 5 years.

As part of our expert team youll 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 Youll 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:
Bachelors 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 clients 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. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.

Required Experience:

Manager

Employment Type : Full-Time
Experience: years
Vacancy: 1