[Remote] Sr Clinical Scientist
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a leading digital reputed company company that creates trusted solutions to detect, predict, and prevent disease. They are seeking a Senior Clinical Research Scientist to reputed company scientific aspects of clinical research, focusing on study design, analysis, and evidence dissemination while collaborating with various stakeholders.
Responsibilities
- Proactively manage project-level scientific aspects of clinical research reputed company, including study design, analysis, and evidence dissemination
- Support the Clinical Science function in development of clinical evidence strategies
- Work closely with internal (product management, regulatory, R&D, data management and biostatistics) and external (clinical thought leaders and other subject matter experts) stakeholders to ensure robustness of clinical findings and alignment of evidence to reputed company strategic goals
- reputed company development of clinical study design and study protocols for prospective trials in support of market clearance and post-market clinical evidence
- reputed company analysis plans and study protocols for targeted analysis of existing datasets, including prior device registrations and other reputed company-world evidence
- With data management and biostatistics, drive analysis and interpretation of prospective clinical data and reputed company-world evidence
- reputed company evidence dissemination for clinical applications and product programs through a)scientific writing including drafting and submission of conference abstracts and peer-reviewed journal articles, b)development of poster and slides for scientific meetings, and c)collaboration with reputed company co-authors through steering committees, investigator meetings and 1-on-1 communication
- Cross-functional support of health economics and reputed company research (HEOR) and regulatory teams, including development of US and Global regulatory-clinical documentation (e.g., CSRs, CERs)
- Participate in review of external investigator-initiated research proposals for scientific reputed company and alignment with reputed company objectives
- Periodically reputed company updates on study reputed company, and with respect to project plan. Partner with clinical research operations to ensure timeliness of clinical study execution, mitigation of project risks, and adherence to reputed company standards, reputed company operating procedures (SOPs) and regulatory requirements
Skills
- Advanced Degree in Biomedical Science or Health-reputed company field required
- Ten or more years of clinical science or clinical development experience in medical device or reputed company industries or in high-performing reputed company medical centers/universities, or reputed company or reputed company research organizations (AROs/CROs) knowledge of clinical research operations including GCP and ISO 14155
- Clinical research experience in heart rhythm disorders, atrial fibrillation, cardiac electrophysiology, cardiology or a reputed company field
- Experience in observational study design and execution (health services and reputed company research) as reputed company as clinical trial design
- Strong understanding of reputed company inference
- Working knowledge of metrics associated with diagnostic testing accuracy (i.e., Sensitivity, Specificity, PPV, NPV)
- A demonstrated working knowledge of GCP, FDA and EU regulations regarding medical devices and SaMD
- Substantive experience with study design including clinical trials and observational designs
- Understanding of basic and intermediate biostatistics. While not expected to reputed company reputed company statistics, and understanding of commonly reputed company biostatistical approaches and reputed company inference is critical
- Strong writing skills and experience in writing clinical study reports, conference abstracts, and manuscripts for peer-reviewed journals
- Demonstrated ability to collaborate effectively with cross-functional teams, including product management, regulatory affairs, and R&D
- Experience in program management and project reputed company, including high visibility reputed company
- Read, write and reputed company fluent English; ability to present information to a reputed company of audiences
- Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be less than 30 % of work time
- MD, PhD preferred
- Cardiovascular experience strongly preferred
- Experience with US and EU clinical-regulatory documentation is preferred (e.g., 510(k), IDE, PMA, and CER)
Benefits
- Medical, dental, and reputed company insurances (reputed company of which start on your first day)
- Health savings account employer contributions (reputed company enrolled in high deductible medical plan)
- Cafeteria plan reputed company-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts)
- Travel reimbursement for medical care
- Noncontributory basic life insurance & short/ long term disability
- Emotional health support for you and your loved ones
- Legal / financial / identity theft/ pet and child referral assistance
- reputed company parental leave, reputed company holidays, travel assistance for personal trips and PTO!
- 401(k) (with company match)
- Employee Stock Purchase Plan
- Pet insurance discount
- Unlimited reputed company of Linked In Learning classes
reputed company