What are the responsibilities and job description for the Clinical Data Specialist (remote) position at Arthrex?
** This position in based in Naples, FL. Remote optional for the right candidate. If remote, travel required to Naples headquarters quarterly for 1 week**
Arthrex is a global medical device company and leader in research, new product development and medical education in orthopedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year that support all aspects of orthopedics. The Orthopedic Research department based in Naples; includes a team of clinical, biomaterials and biomechanical professionals. Arthrex is actively searching for a Clinical Data Specialist to join the Orthopedic Research department. The successful candidate will work alongside the team organizing and overseeing research studies to contribute to advances in the medical community. Experience as a clinical research professional and knowledge of clinical regulatory regulations is required. Excellent communication and analytical skills, and a bachelor’s degree in a related field are required for success in this position. Clinical Research Professional certification is also strongly encouraged. Come join our growing talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Main Objective:
Oversee the day to day operational activities of data management for clinical studies. Lead the development and maintenance of software utilized for data collection.
Essential Duties and Responsibilities:
Support internal clinical data management initiatives
Supervise Clinical Data Associate by establishing responsibilities, empowering their Individual Development Plan and providing ongoing mentoring.
Creates and enforces processes for effective database build and data management in EDC, CTMS and eTMF systems.
Builds the study-specific database using study protocol and configuration specifications.
Is compliant with project and data management plans for data handling and sharing with the clinical research team.
Oversee User Acceptance Testing (UAT)
Supports clinical research team, clinical research sites in the daily use of data systems and ensures adherence to legal and company standards.
Facilitate stakeholder trainings of data management systems.
Lead the edit checks and manual listing review activities according to study specifications.
Manage ongoing query review with closures of system-generated queries at least monthly and before monitoring visits.
Lead the distribution of data reports, extracts and other deliverables as defined in the data management plan.
Conducts data management meetings as appropriate and provides clinical team updates regarding data listings, issues, cleaning and locking.
Lead and coordinate the creation of study-specific eCRF instructions.
Assures databases and archives are protected from security breaches and losses.
Manage troubleshooting activities for data-related problems and provides maintenance or authorizes modification.
Lead QC functions activities – using edit checks, data listings and other available tools/reports, manage quality control of data to ensure accurate, complete data is provided according to study timelines and contract described deliverables.
Manage clinical data cleaning and delivery activities and include database lock.
Develop and maintain data management standard operating procedures, work instructions and training documents
Leads distribution of interim metrics to key stakeholders .
Incidental Duties:
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and really additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor's degree required. Preferably in Business, Life Science or Computer Science.
Master's degree preferred. Preferably in Business, Life Science or Computer Science.
4 years of clinical research data management experience required .
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Thorough knowledge of ICH guidelines, FDA Regulations and GCP including international regulatory requirements for the conduct of clinical development programs, especially related to data handling and processing is preferred.
Prior trial responsibility of the entire data management lifecycle is desirable.
Experience in medical device trial is preferred.
Working knowledge of EDC studies are preferred.
Good knowledge of Clindex system is preferred.
Comprehension of medical terminology or can reference literature for understanding is preferred.
Proficient software skills: Word/ Excel/ Power Point/database is required.
Machine, Tools, and/or Equipment Skills:
PC, Clindex database, SOS, research tools, internet research tools.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Nearest Major Market: Naples
Arthrex is a global medical device company and leader in research, new product development and medical education in orthopedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year that support all aspects of orthopedics. The Orthopedic Research department based in Naples; includes a team of clinical, biomaterials and biomechanical professionals. Arthrex is actively searching for a Clinical Data Specialist to join the Orthopedic Research department. The successful candidate will work alongside the team organizing and overseeing research studies to contribute to advances in the medical community. Experience as a clinical research professional and knowledge of clinical regulatory regulations is required. Excellent communication and analytical skills, and a bachelor’s degree in a related field are required for success in this position. Clinical Research Professional certification is also strongly encouraged. Come join our growing talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Main Objective:
Oversee the day to day operational activities of data management for clinical studies. Lead the development and maintenance of software utilized for data collection.
Essential Duties and Responsibilities:
Support internal clinical data management initiatives
Supervise Clinical Data Associate by establishing responsibilities, empowering their Individual Development Plan and providing ongoing mentoring.
Creates and enforces processes for effective database build and data management in EDC, CTMS and eTMF systems.
Builds the study-specific database using study protocol and configuration specifications.
Is compliant with project and data management plans for data handling and sharing with the clinical research team.
Oversee User Acceptance Testing (UAT)
Supports clinical research team, clinical research sites in the daily use of data systems and ensures adherence to legal and company standards.
Facilitate stakeholder trainings of data management systems.
Lead the edit checks and manual listing review activities according to study specifications.
Manage ongoing query review with closures of system-generated queries at least monthly and before monitoring visits.
Lead the distribution of data reports, extracts and other deliverables as defined in the data management plan.
Conducts data management meetings as appropriate and provides clinical team updates regarding data listings, issues, cleaning and locking.
Lead and coordinate the creation of study-specific eCRF instructions.
Assures databases and archives are protected from security breaches and losses.
Manage troubleshooting activities for data-related problems and provides maintenance or authorizes modification.
Lead QC functions activities – using edit checks, data listings and other available tools/reports, manage quality control of data to ensure accurate, complete data is provided according to study timelines and contract described deliverables.
Manage clinical data cleaning and delivery activities and include database lock.
Develop and maintain data management standard operating procedures, work instructions and training documents
Leads distribution of interim metrics to key stakeholders .
Incidental Duties:
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and really additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor's degree required. Preferably in Business, Life Science or Computer Science.
Master's degree preferred. Preferably in Business, Life Science or Computer Science.
4 years of clinical research data management experience required .
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Thorough knowledge of ICH guidelines, FDA Regulations and GCP including international regulatory requirements for the conduct of clinical development programs, especially related to data handling and processing is preferred.
Prior trial responsibility of the entire data management lifecycle is desirable.
Experience in medical device trial is preferred.
Working knowledge of EDC studies are preferred.
Good knowledge of Clindex system is preferred.
Comprehension of medical terminology or can reference literature for understanding is preferred.
Proficient software skills: Word/ Excel/ Power Point/database is required.
Machine, Tools, and/or Equipment Skills:
PC, Clindex database, SOS, research tools, internet research tools.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Nearest Major Market: Naples
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