Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Principal Clinical Research Scientist at Johnson & Johnson leading clinical research in surgical implants vision. Coordinating cross-functional teams to ensure compliance and deliver evidence-based medical device solutions.
Responsibilities
- Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs.
- Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle.
- Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.).
- Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections.
- Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies.
- Performs other related duties as assigned by management.
Requirements
- An advanced degree in a Scientific Field is required.
- A Doctoral Degree-Optometry or MD with specialty in Ophthalmology is highly recommended.
- Minimum of 8 years of relevant clinical / scientific work experience, including leadership functions (ie. leading or mentoring teams, non-managerial leadership experiences) is required.
- Experience with intraocular lenses is preferred.
- Strong technical writing ability, such as clinical study protocols, reports and abstracts is required.
- Understanding of biostatistics as applied to study data is required.
- Proficient with computers and software programs is required.
- Ability to travel 10% of the time is required.
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation – 120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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