Centralized Monitoring Lead

4 tygodni temu

Warsaw, Polska Allucent Pełny etat

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Centralized Monitoring Lead (CML) to join our A-team (hybrid*/remote). Centralized 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 Centralized Monitoring Lead (CML) coordinates the set-up of study specific processes and the activities of the Centralized Monitoring Analysts (CMAs) during each data review cycle.

In this role your key tasks will include:

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 Centralized 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 centralized 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 centralized monitoring process when required. Coaches/mentors CMA team. Responsible for timelines, budget and quality of Centralized 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, Centralized 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

To be successful you will possess:

Bachelor's degree or equivalent and/or health science background with 5 years of experience in clinical research. Previous experience of centralized 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

Benefits of working at Allucent include:

Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our .

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.” #LI-JC1

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