Clinical Quality Manager overseeing quality assurance and performance improvement in dialysis clinics. Collaborating with interdisciplinary teams to enhance patient care and clinical outcomes.
About the role
- Associate Principal Scientist leading clinical trial scientific activities in Immunology at a global healthcare leader. Collaborating with cross-functional teams to execute Phase 1-4 clinical studies.
Responsibilities
- This position drives scientific planning, strategy and execution of Phase 1-4 clinical studies
- Under the direction of the Program Lead, you will collaborate with global, cross functional team members including clinical directors and study managers to lead/support clinical trial scientific activities.
- Responsible for the clinical/scientific execution of clinical protocol(s)
- Serves as the lead clinical scientist on the clinical trial team
- Collaborates with the Medical Writer on clinical/scientific and regulatory documents
- Partners with Study Manager on study deliverables
- Participates in the set up and design during study start up (e.g., database set up)
- Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with the Clinical Director
- Builds talent and capabilities of direct/indirect team members through proactive coaching, mentoring and development opportunities
- May include management of direct reports including assignment of resources, professional development, and performance management.
- May serve as a subject matter expert and/or participate on process improvement teams.
Requirements
- Bachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +6 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree +2 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
- Degree in life sciences, preferred
- Experience in conducting global clinical trials, including trial initiation through database lock
- Experience in developing protocols and study related documents for Immunology related clinical trials
- Experience with review of participant eligibility for trials (e.g., inclusion and exclusion criteria and prohibited/concomitant medications) with a high focus in Immunology related clinical trials
- Experience in performing medical monitoring in Immunology related clinical trials.
- Advanced communication, technical writing, and presentation skills.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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