Arthrex

Sr. Clinical Study Manager

Arthrex • $100K — $120K *
Naples, FL 34116In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Yesterday
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree required, Master's preferred.
  • 6+ years of clinical research experience needed.
  • Experience in managing research contracts and protocol development is preferred.
  • Clinical Research Certification required or must be obtained within first year.
  • Strong familiarity with federal regulations (FDA, MDR) and research ethics, particularly in a medical device environment.

Responsibilities

  • Lead and oversee clinical studies in compliance with regulations and internal standards.
  • Implement clinical protocols and manage site initiation activities.
  • Coordinate with the Data Management team for data collection through EDC systems.
  • Facilitate communication with IRB and manage study-related documentation.
  • Identify and mitigate quality risks associated with studies, ensuring compliance and efficiency.

Benefits

  • Medical, Dental, and Vision Insurance
  • Flexible Spending Account (FSA)
  • Matching 401(k) Retirement Plan
  • Tuition Reimbursement Program
  • Paid Time Off including Volunteer PTO and Paid Parental Leave
Full Job Description
Requisition ID: 66722 Title:Sr. Clinical Study Manager

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)


Job Details

Date: Jul 1, 2026

Requisition ID: 66722

Salary Range:

Job title: Sr. Clinical Study Manager

Arthrex

Location:

About Arthrex

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. The company's mission is to help surgeons treat their patients better, and the company accomplishes this by providing innovative products and surgical procedures that help surgeons achieve better clinical outcomes. Arthrex has a wide range of products, including devices for sports medicine, foot and ankle, hand and wrist, shoulder and elbow, and orthobiologics. The company also offers medical education programs and resources to help surgeons stay up-to-date with the latest surgical techniques and technologies.
Learn more about Arthrex
Size
14,000 employees
Industry
Healthcare
Net Income
$500 million
Founded
1981
5 Year Trend
+15%
Revenue
$2.3 billion
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Arthrex

More Pharmaceuticals & Biotech Jobs

Find similar Sr. Clinical Study Manager jobs:

NationwideNaples, FL