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.
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 Lead (CML) coordinates the set-up of study specific processes and the activities of the Centralised Monitoring Analysts (CMAs) during each data review cycle. They also lead the review of the findings with study team members, including the sponsor if required.
The CML will perform tasks with minimal supervision whilst assisting, mentoring and supporting the CMA team.
Key Responsibilities
- Liaises with the Project Manager to develop centralised monitoring set up and data review timelines and works with the centralised monitoring team to implement these plans.
- Co-ordinates the creation of the Risk Assessment Categorisation Tool (RACT) with all study team members to agreed timelines.
- Proposes potential Key Risk Indicators (KRI) advising on their configuration and use.
- Creates the Centralised Monitoring Plan with the assistance of study team members.
- Oversees the configuration of the analytics tool to agreed timelines.
- Performs complex analyses and root cause analyses to connect related signal to risks, and responsible for ensuring delivery of high-quality, on time results
- Ensures that all relevant documentation is filed in the eTMF.
- Oversees each centralised monitoring cycle to ensure that all findings are correctly documented and actions agreed with the study team.
- Provides training to the study team regarding the study specific centralised monitoring process when required.
- Coaches/mentors CMA team.
- Responsible for timelines, budget and quality of Centralised Monitoring Team deliverables, identification of risks and issues and escalation to Project Manager (PM).
- Provides input into proposals when required.
- Actively participates in preparation, attendance and presentation of bid defence or any other study related meetings as required.
- Where requested line management responsibility for nominated CMAs.
Working Relationships:
- Typically reports to Director, Centralised Monitoring
- Collaborates with Project Management, Clinical Trial Leaders, Data Management, Medical Monitors, QA and other departments to ensure the safety of subjects and quality of study data
- Liaises with clients as requested by the PM
Requirements
- Bachelor’s degree or equivalent and/or health science background with 5 years of experience in clinical research.
- Previous experience of centralised monitoring is required.
- Ability to manage teams to meet project requirements.
- Understanding of clinical/medical data, including listings and summary metrics.
- Strong customer focus.
- Strong analytical /problem-solving skills / judgment in decision making.
- In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
- 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.
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
- Strong written and verbal communication skills including good command of English language.
Benefits
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Internal growth opportunities and career progression
- More task variety
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
How to Apply: https://apply.workable.com/allucent/j/D31673CF0D/