Clinical Operations Lead

7 dni temu

Warszawa, Mazovia, Polska Allucent Pełny etat

About Allucent

We are a dedicated team helping small to medium-sized biopharmaceutical companies navigate the complex world of clinical trials to bring life-changing therapies to patients globally.

As a Clinical Operations Lead at Allucent, you will be responsible for coordinating and managing Patient Engagement activities across both proposal and study execution stages. This includes Patient Recruitment and Retention, as well as our Patient Direct Trials solutions.

Key Responsibilities
  • You will work collaboratively with the proposal team to develop study-specific strategies addressing individual patient recruitment and retention challenges, and identify Patient Direct Trial opportunities.
  • You will be responsible for developing proposal text and budget alignment with both Patient Recruitment and Retention strategy and PDT strategy.
  • You will attend Bid Defense meetings representing Patient Engagement components of the study strategy.

Patient Recruitment and Retention

You will develop, manage, and deploy specific Patient Recruitment and Retention strategies and tactics, including but not limited to:

  • Recruitment and Retention materials in line with study needs and agreed study scope.
  • Working with digital outreach campaign vendors or managing digital outreach campaigns in line with study timelines and geographical reach.
  • Coordinating site-specific strategies such as Clinical Enrollment Managers, Enrollment Assistants, or other site supporting tactics.
  • Working closely with designated Patient Advocacy Groups to support the study as per agreed scope.

Patient Direct Trials Offering

You will coordinate and manage Allucent's Patient Direct Trials offering:

  • Working closely with our PDT partner and sponsors to ensure PDT deliverables stay on track and on time.
  • Conducting UAT testing of study-specific PDT Patient Apps.
  • Working cross-functionally as required by the PDT scope with other Allucent departments such as Biometrics, Project Management, Consultancy, GCO, and study start-up.

Leadership

  • You will maintain oversight to ensure compliance to SOPs and ICH/GCP/regulatory guidelines and best practices, where needed, initiating course of action to achieve/sustain compliance and efficiency.
  • You will contribute to Patient Engagement system and process improvement initiatives.
  • You will be an active member of the Patient Engagement management team.

Requirements

  • You will possess a Life science, healthcare and/or business degree.
  • You will have minimum 8 years of experience in drug development and/or clinical research.
  • You will have excellent knowledge of ICH/GCP, FDA, and country regulations.
  • You will demonstrate professionalism and presentation of a positive image of the company.
  • You will have strong customer service orientation.
  • You will have excellent communication and listening skills, confronting constructively.

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