Job Description

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You\xe2\x80\x99ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you\xe2\x80\x99ll help make a positive difference in patients\xe2\x80\x99 lives.

Centralised monitoring is a process used to review key data and metrics generated during clinical trials to assess risk. Using statistical analyses, the team works to identify meaningful signals to characterise issues and offer resolutions and a proactive approach to maintaining data quality. The Centralised Monitoring Analyst (CMA) will review outputs from data analytics software to assess the integrity of study data and site performance suggesting corrective and preventive actions where required.

Key Requirements

• Conduct periodic review of site level Key Risk Indicators (KRI) and historic site performance as defined by the Central Monitoring Plan.
• Early identification of site-level risk/issue(s) occurring during study conduct.
• Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit).
• Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Identify and characterize study wide trends in operational and patient clinical trial data using analytical tools.
• Direct study teams to study wide or site-specific issues requiring remedial and preventive actions.
• Establish and maintain effective project/ site level communications with relevant stakeholders.
• Maintain relevant project documents.
• Attend regular team and client meetings, as per the project specific needs.
• Comply with all centralised monitoring requirements as defined by the protocol, SOPs, relevant regulations and guidelines/

• Typically reports to Director, Centralised Monitoring.
• Liaises with Centralised Monitoring Lead to ensure that all study deliverables are achieved to a high standard.
• Collaborates with the project team to ensure the safety of subjects and quality of study data.

• Bachelor\'s degree or equivalent and/or health science background with 2-5 years of experience in clinical research.
• Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred.
• Minimum of 2 year of clinical trial experience with centralised monitoring/data analytics is preferred.
• Strong written and verbal communication skills including good command of English language.
• Solid computer skills, including the ability to learn and use interactive computer systems and good knowledge of MS Office (Word, Excel, PowerPoint
• Results and detail-oriented approach to work delivery and output.
• Understanding of clinical/medical data, including listings and summary metrics.
• Strong analytical /problem-solving skills / judgment in decision making.
• Ability to work productively with direct supervision.
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
• Ability to manage competing priorities.
• Ability to work across cultures and geographies with a high awareness and understanding of cultural differences

Allucent