Senior Feasibility Associate / Feasibility Manager
Precision Medicine Group
Google Cloud Platform
Clinical Trial Manager
Precision Medicine Group
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇷🇸 Serbia
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Act as the hub of central intelligence for assigned studies; lead CRAs and oversee clinical aspects across multiple countries ensuring timeline adherence and quality delivery
- Management and operational delivery of clinical elements: site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
- Ensure successful execution of assigned trials and completion of trial deliverables
- Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) through close collaboration with other functional team members
- Mentor and train team members
- Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor
- Lead CRAs in establishing relationships with 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 high client satisfaction
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 studies across multiple countries in a CRO / Pharma or Biotech company (in a dedicated 'clinical lead' role)
- Significant clinical trial management experience in the area of oncology
- 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
- Core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial managementsite selectionenrollment managementdata cleaningmonitoring planningregulatory documentationoncologyclinical development processGCPICH guidelines
Soft skills
leadershipmentoringcommunicationproblem-solvingrelationship buildingteam collaborationclient satisfactioncross-functional partnershiporganizational skillscreativity