Clinical Data Manager - Globus Medical, Inc.
San Diego, CA
About the Job
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
Position Summary:
Responsible for data management activities including, but not limited to, developing data management plans (DMP) and dictionaries, performing database development, testing, validation, and processing and reviewing clinical study data to ensure the completeness, accuracy, and consistency of the data for subsequent analysis and reporting.
Essential Functions:
+ Designs clinical study databases according to industry-standard methods of clinical data collection, data flow, data mapping, data output, and data lock, and according to specifications outlined in the DMP
+ Develops study-specific DMP, Case Report Form (CRF) completion guidelines (CCG), annotated CRFs, database documentation, edit check specifications, and data transfer processes
+ Partners with study teams to ensure accurate and timely reporting via listings, summaries, and reports
+ Resolves data issues and data cleaning activities including data review, edit check programming, query resolution, and data reconciliation for multiple studies
+ Maintains multiple study databases and data management activities concurrently
+ Works with Data Analytics to compile and maintain the data dictionary
+ Ensures compliance with GCP, SOPs, guidelines, and other relevant regulations
+ Performs database testing, validation, and supports site training and access
+ Performs other duties as assigned
+ Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
+ Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
+ Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
__ _Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions._
Qualifications
+ Proficient in clinical research
+ Intermediate skills in MS Office applications, data visualization, and flow-charting.
+ Proficient in EDC and clinical research software (e.g., iMednet, Medrio, Veeva)
+ Knowledge of CDISC standards, clinical trial design, and regulatory guidelines
+ Solid project management skills with an acute attention to detail
+ Solid ability to interpret data and communicate effectively to others
Our Values :
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
+ Passionate about Innovation : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
+ Customer Focused : We listen to our customers’ needs and respond with a sense of urgency.
+ Teamwork : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
+ Driven : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Equal Employment Opportunity :
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.
Other Duties :
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Position Summary:
Responsible for data management activities including, but not limited to, developing data management plans (DMP) and dictionaries, performing database development, testing, validation, and processing and reviewing clinical study data to ensure the completeness, accuracy, and consistency of the data for subsequent analysis and reporting.
Essential Functions:
+ Designs clinical study databases according to industry-standard methods of clinical data collection, data flow, data mapping, data output, and data lock, and according to specifications outlined in the DMP
+ Develops study-specific DMP, Case Report Form (CRF) completion guidelines (CCG), annotated CRFs, database documentation, edit check specifications, and data transfer processes
+ Partners with study teams to ensure accurate and timely reporting via listings, summaries, and reports
+ Resolves data issues and data cleaning activities including data review, edit check programming, query resolution, and data reconciliation for multiple studies
+ Maintains multiple study databases and data management activities concurrently
+ Works with Data Analytics to compile and maintain the data dictionary
+ Ensures compliance with GCP, SOPs, guidelines, and other relevant regulations
+ Performs database testing, validation, and supports site training and access
+ Performs other duties as assigned
+ Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
+ Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
+ Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
__ _Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions._
Qualifications
+ Proficient in clinical research
+ Intermediate skills in MS Office applications, data visualization, and flow-charting.
+ Proficient in EDC and clinical research software (e.g., iMednet, Medrio, Veeva)
+ Knowledge of CDISC standards, clinical trial design, and regulatory guidelines
+ Solid project management skills with an acute attention to detail
+ Solid ability to interpret data and communicate effectively to others
Our Values :
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
+ Passionate about Innovation : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
+ Customer Focused : We listen to our customers’ needs and respond with a sense of urgency.
+ Teamwork : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
+ Driven : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Equal Employment Opportunity :
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.
Other Duties :
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Source : Globus Medical, Inc.
