Senior Manager Clinical Risk and Analytics
Senior Manager Clinical Risk and Analytics
Posted on :
03-02-2025
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1 Vacancy
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Job Description
Job Title: Senior Manager Clinical Risk and Analytics
Job Location: Great Britain United Kingdom
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Overview
The Senior Manager Clinical Risk & Analytics will report into the DSSE CDM CRA function and is responsible for coordinating crossfunctional risk management and central monitoring activities assessments and analytics for their assigned clinical trials in accordance with ICH GCP E6 requirements.
You will maintain the Risk Management and Centralised Monitoring system as needed and provide risk management and mitigation guidance to study teams ensuring consistency within and across programs.
The Senior Manager Clinical Risk & Analytics will also be tasked with leading risk management compliance with the protocol ICHGCP and/or all applicable local and federal regulatory requirements alongside ensuring patient safety and data integrity. In additional line management responsibility of the Clinical Risk & Analytics team may also form part of this role depending upon candidate experience.
Primary Responsibilities
Our culture: Our peoplefirst culture is guided by our core values: fiercely innovative open culture purposeful urgency passion for excellence and commitment to people and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers one of America's Most Responsible Companies for 2024 by Newsweek a Fast Company Best Workplace for Innovators and a Great Place to Work in Canada France Italy Spain Switzerland and UK – among others.
At Alnylam we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong can bring their authentic selves to work and achieve to their full potential. By empowering employees to embrace their unique differences at work our business grows stronger with advanced and original thinking allowing us to bring groundbreaking medicines to patients.
The Senior Manager Clinical Risk & Analytics will report into the DSSE CDM CRA function and is responsible for coordinating crossfunctional risk management and central monitoring activities assessments and analytics for their assigned clinical trials in accordance with ICH GCP E6 requirements.
You will maintain the Risk Management and Centralised Monitoring system as needed and provide risk management and mitigation guidance to study teams ensuring consistency within and across programs.
The Senior Manager Clinical Risk & Analytics will also be tasked with leading risk management compliance with the protocol ICHGCP and/or all applicable local and federal regulatory requirements alongside ensuring patient safety and data integrity. In additional line management responsibility of the Clinical Risk & Analytics team may also form part of this role depending upon candidate experience.
Primary Responsibilities
- Lead study teams in the identification and management of protocol critical data and process ‘Critical to Quality’ elements safety and data integrity and other protocol execution risks
- Coordinate and lead the execution of Protocol Risk Assessment (PRA)
- Lead the development of the Risk Management and Action Plan (Risk MAP)
- Perform the set up and maintenance of the RiskBased Quality Management (RBQM) system based on study teams requirements data sources and structure
- Perform peer reviews QC and or Validation of study setup in RBQM system vs RBQM Plan and system specifications as required
- Lead definition selection and implementation of Key Risk Indicators (KRIs) and Quality Tolerance Limit parameters (QTLs) and other applicable assessments and dashboards for each study in the RBQM system ensuring consistency with applicable standards
- Work collaboratively with assigned Programmer to implement and refine studyspecific KRIs and QTLs in the RBQM system
- Coordinate and perform as required the execution and review of the study’s assessments and analysis and diagnosing and explaining anomalies identified in the data and risks
- Deliver timely and highquality riskbased monitoring analytics and supports CRM in communication to the crossfunctional study team and CRO (both written report and oral presentation) to identify issue resolution as required
- Lead risk reviews sessions with study teams throughout the study
- Ensure appropriate status and process documentation including studyspecific validation is produced and maintained
- Work with study team to define the most appropriate risk mitigations and contingencies from centralised monitoring signals and findings
- Communicate and/or escalate serious risks and issues to the crossfunctional study team and/or management and Quality as needed
- Coordinate and lead end of trial summarisation of risk management activities including QTL and other issue findings summaries in preparation for inclusion to clinical study report.
- Maintain libraries (Risks KRIs QTLs etc) as required
- Ensure inspection readiness for clinical risk management and centralised monitoring activities on the assigned studies
- Champion RBQM within the company and participates in continuous improvement and development of risk management processes and system as needed
- Train and mentor Clinical Development and CR&A staff in risk and issues management as required
- Extensive experience in a pharmaceutical / biologics / biotechnology company
- Working knowledge of clinical development processes understanding concepts and principles of study design conduct and close out as well as clinical program develop
- Thorough knowledge of Good Clinical Practice/ICH E6 Guidelines and/or other applicable regulatory requirements for the conduct of clinical trials with specific focus on updates about Risk Based Quality Management
- A strong understanding of clinical trials risk management concepts and principles in the Pharma or CRO industry
- Excellent English oral and written communication skills
- Excellent project management capabilities
- Experience with data analytics and data visualisation technologies
- Strong critical thinking and analytical skills and aptitude for data analytics mathematical and statistical concepts is a plus
- Experience and understanding of clinical trial data from various sources (e.g. Clinical devices SDTM RAVE IRT etc.)
- High degree of accuracy and attention to detail
- Ability to work collaboratively in a team environment whilst managing changing priorities to achieve goals/targets
- Ability to build develop and maintain good working relationships with internal and external crossfunctional customer groups
- Strong critical thinking and analytical skills and aptitude for data analytics mathematical and statistical concepts is a plus
- People management experience is preferred but not essential
Our culture: Our peoplefirst culture is guided by our core values: fiercely innovative open culture purposeful urgency passion for excellence and commitment to people and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers one of America's Most Responsible Companies for 2024 by Newsweek a Fast Company Best Workplace for Innovators and a Great Place to Work in Canada France Italy Spain Switzerland and UK – among others.
At Alnylam we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong can bring their authentic selves to work and achieve to their full potential. By empowering employees to embrace their unique differences at work our business grows stronger with advanced and original thinking allowing us to bring groundbreaking medicines to patients.
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Employment Type
Full Time
Key Skills
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