Sr. Clinical Study Manager
Arthrex · Naples, FL · 1 mo ago
AnalystFull-time
We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. No Pay or Schedule unless present. The posting includes Benefits list. No explicit Pay or Schedule. So we include About the role (maybe summary), Responsibilities, Requirements, Qualifications, Skills, Benefits. Need to parse content.
We must not repeat job title as heading. Use
for each section heading. We need to preserve all substantive info, not invent or summarize away detail. Remove boilerplate like EEO etc. Also remove Requisition ID line, maybe include as metadata short p? The instruction: do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. So we can include a short
with Requisition ID maybe. But better to drop it? It says fold minor metadata into a short
or drop it. Could include a short p at top:
Requisition ID: 67724
. That's minor metadata. We'll include that. Now sections: About the role: The posting starts: "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 and supporting clinical studies and projects aligned with Arthrex Research’s clinical research initiatives. The successful candidate will lead and oversee the full lifecycle of multicenter clinical studies, ensuring execution in compliance with research ethics, regulatory requirements, ISO standards, and internal procedures. This individual will drive study strategy, site management, monitoring activities, budgets, and cross-functional collaboration while serving as a key decision-maker for study operations, amendments, and risk management. The role also provides leadership and mentorship to research staff, ensuring the successful delivery of clinical research projects and portfolio objectives. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™." We can put that as About the role. Responsibilities: The "Essential Duties And Responsibilities" list. We need to extract each duty as list items. The text is a long paragraph with many duties separated by periods. We need to split into items. We'll create- for each duty. Must preserve all substantive info; not invent or summarize away detail. We'll break at each sentence that starts with a capital letter after a period? Might be many. We'll try to capture each distinct duty.
Let's list them:
- 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.
That seems comprehensive.
Now Requirements: The "Knowledge And Skill Requirements/Specialized Courses And/or Training" section. We'll extract bullet-like sentences.
List:
- 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.
Now Education And Experience: We'll treat as Qualifications maybe. The section "Education And Experience". We'll extract:
- 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.
We could split into Qualifications (education/experience) and Skills (maybe technical skills). But we have separate Skills section; we could put technical skills like proficiency in Microsoft Office, data organization, etc. However the instruction: Use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we need to map content accordingly.
We have:
- About the role: summary paragraph.
- Responsibilities: list of duties.
- Requirements: knowledge and skill requirements (maybe includes both knowledge and skill). Could be "Requirements".
- Qualifications: education and experience.
- Skills: maybe specific skills like communication, strategic thinking, etc. But we already put many in Requirements. Could separate: Requirements = knowledge/skill requirements (like strategic thinking, understanding processes, etc). Qualifications = education/experience. Skills = maybe technical skills like Microsoft Office, data organization, technical writing. But we have overlapping.
Better to follow typical job posting: Requirements = knowledge/skill requirements; Qualifications = education/experience; Skills = maybe specific competencies (like communication, technical writing). However we have limited distinct sections. We'll decide:
- Requirements: the bullet list under "Knowledge And Skill Requirements/Specialized Courses And/or Training".
- Qualifications: the bullet list under "Education And Experience".
- Skills: maybe we can extract from responsibilities that are skill-based? But to avoid duplication, we could put Skills as empty? But we must not emit heading with filler. So we should only include Skills if there is real specific content not already covered. Could we extract "Strong research and technical writing skills and ability to review protocols and agreements for accuracy." and "Ability to organize and review data sets" and "Proficiency in Microsoft Office programs". Those are skills. They appear under Education And Experience but could be considered skills. However they'd be duplicated if we also put them in Qualifications. To avoid duplication, we could put them under Skills and keep Qualifications just education/experience years. Let's see.
Education And Experience includes: Bachelor’s degree required; Master’s degree preferred; 6 plus years 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.
We could split: Qualifications: education and experience (degrees, years, industry). Skills: technical skills (research/technical writing, data organization, MS Office, certification). That seems reasonable.
Thus:
Qualifications:
- 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.
Skills:
- 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.
Now Benefits: list.
We need to output HTML fragment only.
Let's craft.
Start with optional metadata p:
Requisition ID: 67724
ThenAbout the role
... paragraph ...
ThenResponsibilities
- ... each duty ...
Requirements
- ... each requirement ...
Qualifications
- ... each qualification ...
Skills
- ... each skill ...
Benefits
- ... each benefit ...