Quality Manager overseeing quality management systems and leading quality assurance personnel at DRS Pivotal Power, a high reliability power conversion equipment manufacturer.
About the role
- Leads operational planning and execution of one or more clinical trials as part of a global, cross-functional team in clinical drug development. Opportunity to demonstrate leadership and technical skills while collaborating with stakeholders.
Responsibilities
- Responsible for the operational planning, feasibility, and execution of a clinical trial
- May serve as the clinical trial team lead
- May lead team in key study planning, development, and execution elements (e.g., data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update reports, study close out activities)
- Leads team for timeline management, risk identification and mitigation, issue resolution
- May facilitate and collaborate with key internal/external stakeholders (e.g., study team, country teams, vendors, committees) in support of clinical study objectives
- Accountable for managing any study specific partners and/or vendors.
Requirements
- Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree
- Degree in life sciences, preferred
- Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
- Ability to manage multiple competing priorities with good planning, time management and prioritization skills
- Solid understanding of the principles of project planning & project management
- Good analytical skills to drive operational milestones
- Intermediate knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)
- Experience in conducting global clinical trials, including trial initiation through database lock. Highly Preferred: experience in conducting clinical trials in ophthalmology
- Experience in managing and driving operational activities on protocols for ophthalmology clinical trials.
- Experience with imaging vendors, clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee for ophthalmology clinical trials.
- Experience with ophthalmologic assessments, e.g (slit lamp. dilated indirect ophthalmoscopy {DIO}, imaging assessments such as optical coherence tomography {OCT}; fluorescein angiography {FA}, fundus photography {FP} and visual acuity assessments such as best corrected visual acuity {BCVA} performed and as well as supplies and equipment needed at sites in ophthalmology clinical trials.
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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