Sr CM Analyst I

Job Description

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 Centralized Monitoring 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. Centralized Monitoring 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.

Centralized Monitoring is an integral part of PPD’s risk-based monitoring (RBM) strategy and supports centralized monitoring efforts. Ongoing data assessments from our Centralized Monitoring 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 Centralized Monitoring group's centralized statistical monitoring approach identifies risk signals that may be difficult to detect through traditional review methods, such as on-site monitoring.

Centralized Monitoring 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.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.  

Summarized Purpose: 

Identities and characterizes issues and trends in operational and patient clinical trial data using analytical or statistical tools. Leverages operational experience and knowledge to evaluate issues and develop findings based on data analyzed to communicate issues and potential risks to project team members for follow-up action. Begins to develop a Centralized Monitoring specialization and may execute Centralized Monitoring lead tasks or function as the lead on projects.

Essential Functions:  

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 Centralized Monitoring 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 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 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, including project team, functional management and client contacts

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, such as protocols, electronic study data systems and to identify trending of site/study data

Firm prioritization skills with ability to plan, monitor and manage workload fluidly in response to changing project demands

Strong understanding of project protocol, project documentation including Centralized Monitoring Plan and other functional plans

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.   

PPD Defining Principles:

- 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.