Top 2 Senior scientist Jobs in Naples, Fl

Sr. Clinical Study Manager
Arthrex —Naples, FL
- 6 years
- Office
- Master's degree
- Paid parental leave
- Dental insurance

Check out these similar jobs

Based on your search for senior scientist jobs.

Sr. Clinical Study Manager
Arthrex —Naples, FL
Leads the implementation of clinical protocols, informed consent forms, and study-related materials for clinical studies. Three-year Sponsor/CRO preferred.

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Senior Scientist
Qnity —Circleville, OH
Experience with Design of Experiments and Green Belt certification preferred. Ability to work with market and business leaders to develop key new product…
Senior Environmental Scientist
Los Alamos Technical Associates, Inc. —Columbus, OH
Demonstrated experience leading technical portions of proposals, including scopes, staffing assumptions, technical approaches, and cost estimates.
9d

Show more jobs in cities nearby

I want to receive the latest job alert for senior scientist in naples, fl

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

senior scientist jobs near naples, fl

Remote Clinical Care Manager jobs in California

Clinical Study Manager jobs in Boulder, CO

Clinical Study Manager jobs in North Carolina

Study Abroad Coordinator jobs in Boston, MA

Hotel Manager jobs in Anaheim, CA

Clinical Study Manager jobs in New Jersey

Sr. Clinical Study Manager

Arthrex -
Naples, FL

Apply Now

Job Details

Benefits

Paid parental leave
Dental insurance
Flexible spending account
Tuition reimbursement
Paid time off
Parental leave
Employee assistance program
Vision insurance
401(k) matching
Life insurance
Food provided

Qualifications

Medical law
ISO standards
Research project design
Bachelor's degree
Biomedical regulatory compliance
Project stakeholder communication
Cross-functional communication
FDA regulations

Full Job Description

Requisition ID:

66722

Title:

Sr. Clinical Study Manager

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Clinical Study Manager. This individual will be responsible for leading, developing, managing, and facilitating activities related to the conduct of clinical research studies. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

This is an onsite position based at our global headquarters in Naples, Florida.

Essential Duties and Responsibilities:

Leading, planning, executing, managing, and oversight of clinical studies according to research ethics guidelines, ISO standards, internal SOPs, applicable regulations, and portfolio priorities.
Leads the implementation of clinical protocols, informed consent forms, and study-related materials for clinical studies.
Manages site initiation activities (e.g., study start-up documentation preparation)
Responsible for IRB communication, including document preparation and submission of Arthrex study initiatives.
Implementing modifications to optimize protocol results or edit/amend study documentation if necessary.
Collaborate with Data Management team to ensure the electronic data capture system (EDC) is designed to collect all required data per the protocol.
Responsible for training internal staff assigned to studies.
Project lead for other research staff assigned to multicenter studies.
Key decision maker for study amendments and strategies
Maintain appropriate monitoring and maintenance of clinical sites to ensure the overall successful conduct of assigned clinical studies.
Oversee all aspects of the assigned clinical projects, including essential documents, electronic data collection, change management, risk management, and monitoring activities.
Set-up and maintain accurate progress and Site study status tracking logs to provide reports and updates of assigned clinical research projects.
Oversee follow-up and lead query resolution with sites via ongoing interactions.
Participation in investigator meetings, Site initiation, monitoring, and close-out visits when applicable
Complete central, remote, and on-site monitoring reports and follow-up letters
Complete monitoring report reviews of other staff
Oversee monitoring activities for the assigned projects and is responsible for ensuring actions are taken when applicable.
Identify and mitigate quality risk and/or issues associated with assigned studies/activities.
Facilitate appropriate documentation to maintain compliance with the Finance and Compliance departments.
Prepare and track clinical study budgets that include both sponsor costs and sites costs.
Responsible for the timely completion of deliverables, inclusive of contributing to interim and final study reports
Facilitate efficient utilization of available clinical data, addressing the needs of internal and external stakeholders (e.g., publications)
Works closely with leadership, product management, medical writing, project manager, and other research staff to manage assigned studies.
Conducts regular investigator meetings to ensure protocol compliance and site engagement.
Actively participate in research committees, study groups, and cross-functional portfolio governance activities to support continuous improvement and strategic alignment
Engage in and support departmental initiatives and cross-functional team projects, collaborating by driving execution, problem-solving, and achievement of key business outcomes.
Conducts project huddles and able to lead cross-functional projects.
Mentoring and training staff
Serve as a cross-functional lead within an assigned study and product portfolio, ensuring alignment across Clinical Operations, Product Management, Data Management, Regulatory, Compliance, and other key stakeholders

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Strong strategic thinking with the ability to translate goals into actionable project plans.
An understanding of cross-functional clinical study processes is required.
Ability to work in a team, good communication, documentation, and a strong understanding of data collection and analytical processes are required.
The ability to identify a research hypothesis and proposed outcome measures to address the hypothesis is required.
The ability to read a surgical technique and have a basic understanding of the instruments necessary to perform the procedure is required.
Able to communicate effectively with physicians, key opinion leaders, and other healthcare personnel.
Must have a strong understanding of federal regulations relating to clinical studies (FDA, MDR), ISO, and research ethics.
Experience in managing research contracts and protocol development is preferred.
Experience in post-market, real world evidence, longitudinal or health economics studies is preferred.
Ability to generate and develop ideas that drive efficiency and impact organizational goals.
Ability to approach challenges with an innovative, solution-oriented mindset.

Education and Experience:

Bachelor’s degree required. Master’s degree preferred.
6 plus years of related clinical research experience required.
Three-year Sponsor/CRO preferred. Preferably, in a medical device industry environment
One year of clinical research monitoring or study manager experience required.
Familiarity with orthopedics and medical terminology is preferred.
Strong research and technical writing skills and ability to review protocols and agreements for accuracy.
Ability to organize and review data sets
Proficiency in Microsoft Office programs
Clinical Research Certification required or must be willing to obtain within 1 year of employment.

Arthrex Benefits

Medical, Dental and Vision Insurance
Company-Provided Life Insurance
Voluntary Life Insurance
Flexible Spending Account (FSA)
Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
Matching 401(k) Retirement Plan
Annual Bonus
Wellness Incentive Program
Free Onsite Medical Clinics
Free Onsite Lunch
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.

Apply Now

Refine Your Search

senior scientist jobs in naples, fl

Sr. Clinical Study Manager

Check out these similar jobs

Explore jobs in cities nearby

I want to receive the latest job alert for senior scientist in naples, fl

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected