Clinical Monitoring Analyst (Various Levels) - UK 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.
Data Analytics is an integral part of PPD's risk-based monitoring strategy, driving centralized monitoring efforts through a new approach to risk surveillance and centralized statistical monitoring. This approach combines the power of statistical and analytical tools with expertise from operationally experienced staff to analyze and monitor clinical trial data. Data Analytics' staff (CDLs) holistically explore study data to pinpoint meaningful signals, resulting in more efficient and effective resolution of issues and a proactive approach to risk detection. Using this data driven approach, study teams are able to quickly address systemic problems or site performance, directing remediation activities where needed, and positioning on-site monitoring activity in a targeted approach.
As a Clinical Monitoring Analyst, you'll be supporting centralized statistical and risk surveillance activities on assigned trials. You will Leverage your operational experience and knowledge to evaluate issues and develop findings based on data to communicate issues and potential risks to project team members for follow-up action. We are open to applicants at various levels (CMA I/II, Sr CMA)
Qualifications:Requirements: Education / Experience:
- Reviews clinical trial data using a variety of tools and systems in alignment with the centralized monitoring plan with support from senior team members.
- Characterizes and tracks the evidence of issues, signals and potential risks with support from senior team members.
- Ensures results of reviews are appropriately documented per department procedures.
- May participate in development of risk characterization and reporting.
- Supports review set-up, including updating department database, pulling reports, etc
Knowledge, Skills and Abilities:
- 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 2+ years'). Prior experience in clinical monitoring, data management, biostatistics or related field in support of clinical trials is preferred, experience with Data Analysis is essential
- Capable of applying fundamental 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
- Good analytical /problem-solving skills /judgment in decision making
- Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
- Flexibility and adaptability
- Ability to work in a team environment and independently
- Good oral and written communication skills (English) with the ability to communicate with a variety of internal customers, including project team
- Good computer skills, with knowledge of MS Office (Word, Excel, PowerPoint) and the ability to learn and use interactive computer systems
- Ability to extract pertinent information from standard study documentation, such as protocols, electronic study data systems with the ability to learn to identify trending of site/study data
- Prioritization skills with ability to plan, monitor and manage workload fluidly in response to changing project demands
- Satisfactory understanding of project protocol, project documentation including Centralized Monitoring
- Broad understanding of medical/therapeutic area knowledge and of medical terminology
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