Clinical Trial Manager – Senior
Precision Medicine Group
full-time
Posted on:
Location Type: Remote
Location: Romania
Visit company websiteExplore more
Job Level
Tech Stack
About the role
- 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
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
- Health insurance
- 401(k) retirement plans
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementdata cleaningmonitoring planningenrolment managementregulatory documentationGCPICH guidelinesmedical terminologyclinical development processoncology
Soft Skills
communicationmentoringteam leadershipproblem-solvingrelationship buildingcross-functional collaborationclient satisfactioncreative action planningorganizational skillseffective oversight