Precision Medicine Group

Clinical Trial Manager / Senior Clinical Trial Manager

Precision Medicine Group

full-time

Posted on:

Location Type: Remote

Location: Slovakia

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • We have an opportunity for an experienced Clinical Trial Manager to join our growing team. Candidates can work remotely in UK, Hungary, Poland, Romania, Serbia or Slovakia.
  • You will be the hub of central intelligence for the studies you will be managing and will lead CRAs and oversee all clinical aspects of your study across multiple countries, ensuring timeline adherence and scope, whilst ensuring quality delivery. We encourage high-energy, dedicated professionals who enjoy a challenge, thrive in the details and flourish in dynamic environments to explore this opportunity.
  • We are addressing the challenges facing the research and development of novel compounds in Oncology and are dedicated to positively impacting the health and lives of patients around the world. If you take a consultative approach to trial management, proving to be a valuable partner in the trial operational delivery process, don't miss exploring working with us.

Requirements

  • Bachelor’s degree or equivalent combination of education/experience in science or health-related field, including experience in the field of oncology
  • Demonstrable experience leading clinical aspects of your studies across multiple countries in a CRO / Pharma or Biotech company (in a dedicated 'clinical lead' role).
  • Working knowledge of GCP/ICH guidelines and the clinical development process
  • Availability for domestic and international travel including overnight stays
  • Must be able to communicate effectively in the English language
  • Demonstrated computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
  • Demonstrated ability to develop positive working relationships with internal and external organizations
  • Demonstrates core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan
  • Demonstrates mastery knowledge of ICH-GCP, meaningful Precision SOPs, and regulatory guidance, as well as the ability to implement
Benefits
  • Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
  • Successful execution of assigned trials and ensuring completion of trial deliverables
  • Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members
  • Mentoring and training of team members
  • Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor
  • Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities
  • Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial managementoncologyGCPICH guidelinesclinical development processmedical terminologyclinical trial activities
Soft Skills
communicationrelationship buildingleadershipproblem-solvingattention to detailadaptability