Centralized Monitoring Analyst

4 dni 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 Analyst (CMA) to join our A-team (hybrid*/remote). As a CMA at Allucent, you undertake the review of trial data at Allucent as part of the centralizer monitoring activities. This position monitors outputs from data analytics software and/or listings to assess the integrity of study data and site performance suggesting corrective and preventive actions where required. The CMA is a member of the Centralized Clinical Trial Services staff.

In this role your key tasks will include:

  • 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 suggest 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 centralized monitoring requirements as defined by the protocol, SOPs (Standard Operating Practices), relevant regulations and study specific plans.
  • Actively support to staff learning & development within the company
  • Draft and contribute as Subject Matter Expert (SME) in the field of Centralized Monitoring Analyst activities to the evaluation/improvement of processes and procedures within the Quality Management System
  • Assure good communication and relationships with (future) clients
  • Contribute and take part in client evaluations and visits.
  • Contribute to other areas of business as required

Requirements

To be successful you will possess:

  • Life science, healthcare and/or business degree.
  • Minimum 2 years of relevant work experience.
  • Minimum 2 years of experience in drug development and/or clinical research.
  • Good knowledge of GCP and applicable (local) regulatory requirements.
  • Good understanding of role of data in clinical trials role of site staff in the collection of this data.Strong analytical and critical thinking to understand causes of findings and identify potential corrective and preventive actions.
  • Strong written and verbal communication skills including good command of English language
  • Representative, outgoing and client focused
  • Ability to work in a fast-paced challenging environment of a growing company
  • Administrative excellence 
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint required

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 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 global offices.

“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.”

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