Medical Monitor US Board-Certified Hematologist
Medical Monitor US Board-Certified Hematologist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners while always focusing on patients safety and wellbeing.
HomeBased in the United States
Responsibilities:
- Advise clients project teams sites data safety monitoring boards regulatory agencies and thirdparty vendors on medical matters
- Collaborate with internal departments in the preparation of clinical development plans protocols investigator brochures annual reports clinical study reports manuscripts and different scientific presentations
- Review and analysis of clinical data to ensure the safety of study participants in clinical studies
- Ensure that the reported data is accurate complete and verifiable and that the conduct of the trial is in compliance with the currently approved protocol/amendments
- Address safety issues across the study from sites and the study team
- Review listings for coded events to verify Medical Dictionary for Regulatory activities
- Participate in bid defense meetings
- Assist in Pharmacovigilance activities
- Identify Program risks and create and implement mitigation strategies with Clinical Operations
- Ability to organize and lead clinical development advisory boards and safety monitoring boards
- Ensure Study team compliance with FDA EMEA ICH and GCP guidelines
- Review and sign off clinical documents with respect to medical relevance.
Qualifications :
- Medical Doctor degree required
- US Board Certification in Hematology required
- Experience as a practicing Hematologist (minimum of 10 years)
- Clinical Research experience required such as experience as a Principal Investigator or SubInvestigator
- Full working proficiency in English
- Proficiency with MS Office applications
- Excellent communication and presentation skills comfortable public speaking
- Problemsolving team and detailoriented
Additional Information :
As part of PSIs Medical Monitoring team you will join our international group of medical professionals build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
Company Industry
Key Skills
- Time Management
- Diplomatic Skills
- Risk Management
- Influencing Skills
- Organizational Skill
- Accounting & Finance
- Strategy Management
- People Management
- Industril Knowledge
- Communication
- Negotiation Skills
- Strategic Thinking Skills
- Leadership Skill
- Problem Solving Skills
- Regulatory&Governance
