Work Schedule
Other
Environmental Conditions
Office
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.
Centralized Monitoring (CM) is an integral part of PPD’s risk-based quality management (RBQM) strategy. We deliver risk surveillance and centralized statistical monitoring, combining the power of statistical and analytical tools with expertise from operationally experienced staff to monitor and manage clinical study data. Ongoing data assessments from our Centralized Monitoring group facilitates dynamic adaptation of monitoring plans with a focus on critical-to-quality risks that drive data quality and have the greatest impact on data integrity and subject safety.
As a Senior Centralized Monitoring Analyst, you’ll be supporting RBQM Strategy and centralized statistical and risk surveillance activities on assigned trials.
Summarized Purpose:
As a Senior Centralized Monitoring Analyst, you’ll act as a subject matter expert and interdepartmental and client liaison for CM activities, including centralized statistical and risk surveillance activities as well as supporting RBQM strategy. Areas of focus includes project lead for one or more projects, including set-up of functional plans, tools and delivery of review cycles, working closely with clients and other functional leads to evaluate end-to-end data strategy risk and advocate for risk mitigation strategies.
Essential Functions:
- Serve as functional lead knowledgeable in RBQM methodologies, tools, processes, and central monitoring methods, tools, and systems.
- Successfully influences study functional leads, with a focus on driving RBQM strategy, end to end data risk management and defining mitigations including proper monitoring strategy for critical-to-quality data and processes.
- Ensures 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.
- Provides training and guidance to junior team members.
- Project leadership activities include: Leads the design and setup of study specific tools and centralized monitoring plan for data review; manages review timelines, develops analysis assignments for team, and supports budget management; organizes, communicates with internal team, and delegates as appropriate to ensure reviews are completed on-time, on budget, with high quality; assists with report development, delivers reports, and leads centralized monitoring meetings; contributes to risk assessment through the completion of the department risk assessment tools. Participates in the cross-functional risk assessment review meetings and contributes to overall risk planning and monitoring strategy.
- Specialist activities included focused efforts on the development of new tools and analyses within area of specialty.
Education and Experience:
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 5+ 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 enough for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Capable of applying in-depth knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations
- Strong attention to detail and skill with numbers
- Substantial analytical /problem-solving skills /judgment in decision making
- Ability to work independently and organize and coordinate activities across the team
- Demonstrated ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
- Proven flexibility and adaptability
- Ability to work and lead in a team environment and independently
- Strong oral and written communication skills (English) with the ability to communicate effectively with a variety of internal and external customers, including project team, functional management and client contacts
- Strong computer skills, with solid knowledge of MS Office (Word, Excel, PowerPoint) and the ability to learn and use interactive computer systems
- Complete ability to extract pertinent information from standard study documentation, such as protocols, electronic study data systems and to identify trending of site/study data
- Solid prioritization skills with ability to plan, monitor and manage workload fluidly in response to changing project demands
- Comprehensive understanding of project protocol, project documentation including Centralized Monitoring Plan and other functional plans
- Ability to serve as a subject matter expert and lead on projects cross-functionally
Working Environment:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to lift and move objects up to 25 pounds
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
