About the Role:Leads efforts to support the operational activities for planning, initiation, conduct and close out of assigned Clinical Studies (domestic and global studies). Key contributor to clinical studies using Contract Research Organizations (CROs) and internally run studies.
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Your Contributions (include, but are not limited to):- Partnering with the Clinical Trial Managers (CTM), ensures clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies
- Serves as lead on smaller studies and/or team member for of assigned clinical studies
- Develops reports and provide insights for technical and study design discussions
- Manages projects plan, tracking metrics, issues lists and resolution for contract research organizations (CROs) and other contract service providers (CSPs) for assigned studies
- Participate in and leads some study team meetings. Working with CTM, creates study timelines in accordance with corporate goals. Helps with recruitment efforts
- Participates (may lead smaller) in internally run studies (without CROs) including creating draft monitoring plans, documenting on-site monitoring guidelines, forms, tools and participate in onsite monitoring and co-monitoring visits, as necessary
- Works collaboratively with clinical operations department in documenting NBI standard processes across assigned clinical programs. May train lower level Specialists
- Other duties as assigned
Requirements:- BS/BA in Scientific field or equivalent AND 4+ years of clinical trials or operations experience, CRO/Vendor Management exposure is preferred. Participation in monitoring clinical trials or related experience required OR
- Master's degree in Scientific field or equivalent AND 2+ years of similar experience noted above
- Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
- Works to improve tools and processes within functional area
- Ability to work as part of team and may train lower levels
- Excellent computer skills
- Strong communications, problem-solving, analytical thinking skills
- Sees impact on department and clinical function
- Ability to meet multiple deadlines across a project/program, with a high degree of accuracy and efficiency
- Strong project management skills
- Ability at analyzing data and information to derive options/recommendations for management considerations
- Job Specific Knowledge & Qualifications:
- Strong knowledge of the clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directives
- Solid understanding of clinical operations, specifically conducting clinical studies from start-up through close-out.
- Trial management protocol and process understanding
- Solid understanding of Clinical Research industry and the relevant environments in which it operates
- Ability to design, plan and execute activities and works well under changing circumstances; manages time effectively
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The annual base salary we reasonably expect to pay is $110,800.00-$151,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
