Clinical Development Lead

16 ore fa


Roma, Lazio, Italia Clinchoice Inc. A tempo pieno

Clinical Development Lead at Clinchoice Inc.

We are seeking a seasoned Clinical Project Manager/Director to lead our clinical development initiatives. This role will oversee the operational management of clinical trials from study design until study close-out, ensuring timely and budget-friendly completion in line with quality standards and regulatory requirements.

Main Responsibilities:

  • Oversight of clinical trials, guaranteeing on-time and cost-effective completion while adhering to ICH, GCP, and SOPs.
  • Design and development of full protocol synopses through collaboration with cross-functional teams.
  • Primary contact for the CRO, managing day-to-day relationships and raising issues promptly.
  • Study budget management, scope changes, and financial reconciliation.
  • Preparation and coordination of scientific meetings, including KOLs, Investigators', and blinded review meetings.
  • Preparation, review, and approval of Clinical Study Reports in cooperation with Medical Writers and key stakeholders.
  • Reporting to senior management.
  • Operational management coordination of assigned projects.
  • Clinical Development Plan (CDP) definition focusing on studies' operational aspects.
  • Interactions with functions supporting the Clinical Development Plan.
  • Line Management of Clinical Project Managers (CPMs).

Requirements:

  • University Degree in a scientific or health-related discipline, or equivalent.
  • Proven experience as a Clinical Project Manager.
  • Strong knowledge of clinical study design, clinical trial operations, GCP/ICH Guidelines, and other applicable regulations.
  • Familiarity with planning tools and principles.
  • Proficiency in Microsoft Office.
  • Fluency in English and local language(s).
  • Willingness to travel.

The ideal candidate will have excellent leadership skills, strong communication abilities, and the ability to manage multiple priorities effectively. A salary range of $120,000 - $180,000 per year is available for this position, commensurate with experience. We offer a competitive benefits package and opportunities for professional growth.



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