Senior Centralized Monitoring Analyst – UK (Home based)
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
PPD's data analytics group delivers a new approach to 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. Data analytics staff explores study data holistically to pinpoint meaningful signals, resulting in more efficient and effective issue resolution and a proactive approach to risk detection. Using this data-driven approach, PPD can address study problems or site performance quickly, directing remediation activities where needed and positioning on-site monitoring activity in a targeted approach.
Data analytics is an integral part of PPD’s risk-based monitoring (RBM) strategy and supports centralized monitoring efforts. Ongoing data assessments from our data analytics group allows to adapt monitoring plans dynamically so that CRAs can focus on the factors that have the greatest impact on data integrity and subject safety. Regardless of the percentage of source data verification (SDV), the data analytics group's centralized statistical monitoring approach identifies risk signals that may be difficult to detect through traditional review methods, such as on-site monitoring.
Data analytics evaluates data within and across studies, sites, countries and regions. Our analytic approach provides insight into:
- Data errors, deviations
- Trends, outliers
- Unusual variation (or lack of variation)
- Potential data manipulation, fraud
- Other systematic errors or data integrity issues.
As a Senior Centralized Monitoring Analyst, you’ll be supporting centralized statistical and risk surveillance activities on assigned trials.
- Independently reviews and analyzes clinical trial data using a variety of tools and systems in alignment with the centralized monitoring plan, flexing review assignments across the majority of different analyses.
- Characterizes and tracks the evidence of issues, signals and potential risks.
- Performs complex analyses and root cause analyses to connect related signal to risks, and responsible for ensuring delivery of high-quality, on time results.
- May participate in lead activities, such as contribution to the development of the centralized monitoring plan, department risk assessment tool and cross-functional risk assessment meetings, risk reports and generating findings reports following review cycles.
- May function as the data analytics lead on some projects.
- Provides training and guidance to junior team members.
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious 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.
Skills and Abilities:
- Capable of applying strong 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
- Strong analytical /problem-solving skills /judgment in decision making
- Ability to work productively with direct supervision
- Demonstrated ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
- Demonstrated flexibility and adaptability
- Ability to work in a team environment and independently
- Solid oral and written communication skills (English) with the ability to communicate effectively with a variety of internal and external customers
- Solid computer skills, with good knowledge of MS Office (Word, Excel, PowerPoint) and the ability to learn and use interactive computer systems
- Comprehensive ability to extract pertinent information from standard study documentation and to identify trending of site/study data
- Firm prioritization skills with ability to plan, monitor and manage workload fluidly
- Strong understanding of project protocol, project documentation including Centralized Monitoring Plan and other functional plans
At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.