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Clinical Data Manager

Job Description

The Clinical Data Manager II is responsible for managing and coordinating all aspects of the data management process in support of research activities within the Infectious Disease Clinical Research Program. The incumbent will be a member of the Data Coordination Center, which is responsible for providing data processing and analytical support to the Infectious Disease Clinical Research Program. Responsibilities include study planning, development of CRFs and other data collection instruments, coordination of other DCC study team member activities, development and maintenance of the data management plan, data entry guidelines and coding manuals, generation and distribution of reports and data forms, data validation and data clarification resolution, and site training as needed for specific studies.
Responsibilities:
Interact with Clinical Research Managers and Principal Investigators to assess study needs and plan study activities
Lead a multi-functional team of data-related resources including data system programmers, data entry clerks, and SAS and Oracle programmers.
Work with project management staff to define timelines of assigned studies to ensure study milestones are met.
Represents Data Management (and the DCC generally) during study team meetings, regularly informing project management of overall study data status and potential issues for resolution.
Work with project management and DCC study team to determine data to be collected and to develop data collection instruments, including annotated documentation.
Develop and maintain study-specific Data Management Plans.
Develop and maintain study-specific Data Cleaning and Validation Plans.
Develop other study-specific documentation manuals including data entry instructions and guidelines, coding manuals and Standard Operating Procedures, as needed.
Perform EDC data collection instrument User Acceptance Testing.
Record the receipt, track and distribute research documents through the data management and verification process in a timely and accurate fashion.
Maintain files for storage of research documents.
Generate and distribute reports as necessary. This includes batch reports run on daily, weekly, and monthly cycles, status reports as well as any special purpose ad hoc reports.
Manage query submission, tracking and resolution for single complex studies or group of studies under direction of more senior data managers.
Review study databases for incomplete/missing data and other data issues.
Oversee the activities of other DCC staff assigned to manage studies.
Reconcile discrepancies and obtains guidance when values are questionable or illegible.
Interact with clinical personnel to resolve omissions, discrepancies or any other data management issues.
Mentor junior Data Managers on standards, DM practices and Quality Assurance practices.
Generate, distribute, track, enter resolution, annotate and file data entry reconciliation reports and data clarifications.
Verify computer-generated output against original data.
Check work for accuracy on a daily basis according to established procedures.
Report any system/data errors and/or problems to their supervisor.
Assist clinical users in database interaction as necessary, performing queries upon supervisor's direction.
Adhere to a policy of strict confidentiality concerning all documents, data, and information maintained within the department.
Adhere to department Standard Operating Procedures for all data management responsibilities.




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 

Job Snapshot

Location US-MD-Bethesda
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Biotech, Pharmaceutical, Research
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Company Overview

Aerotek

We know that a company’s success starts with its employees. We also know that an individual’s success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek’s people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With more than 230 non-franchised offices, Aerotek’s 6,000 internal employees serve more than 300,000 contract employees and 17,000 clients every year. To learn more, visit Aerotek.com. Learn More

Contact Information

US-MD-Bethesda
Nathalie Karam
3012504323
Snapshot
Aerotek
Company:
US-MD-Bethesda
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Biotech, Pharmaceutical, Research
Store Type:

Job Description

The Clinical Data Manager II is responsible for managing and coordinating all aspects of the data management process in support of research activities within the Infectious Disease Clinical Research Program. The incumbent will be a member of the Data Coordination Center, which is responsible for providing data processing and analytical support to the Infectious Disease Clinical Research Program. Responsibilities include study planning, development of CRFs and other data collection instruments, coordination of other DCC study team member activities, development and maintenance of the data management plan, data entry guidelines and coding manuals, generation and distribution of reports and data forms, data validation and data clarification resolution, and site training as needed for specific studies.
Responsibilities:
Interact with Clinical Research Managers and Principal Investigators to assess study needs and plan study activities
Lead a multi-functional team of data-related resources including data system programmers, data entry clerks, and SAS and Oracle programmers.
Work with project management staff to define timelines of assigned studies to ensure study milestones are met.
Represents Data Management (and the DCC generally) during study team meetings, regularly informing project management of overall study data status and potential issues for resolution.
Work with project management and DCC study team to determine data to be collected and to develop data collection instruments, including annotated documentation.
Develop and maintain study-specific Data Management Plans.
Develop and maintain study-specific Data Cleaning and Validation Plans.
Develop other study-specific documentation manuals including data entry instructions and guidelines, coding manuals and Standard Operating Procedures, as needed.
Perform EDC data collection instrument User Acceptance Testing.
Record the receipt, track and distribute research documents through the data management and verification process in a timely and accurate fashion.
Maintain files for storage of research documents.
Generate and distribute reports as necessary. This includes batch reports run on daily, weekly, and monthly cycles, status reports as well as any special purpose ad hoc reports.
Manage query submission, tracking and resolution for single complex studies or group of studies under direction of more senior data managers.
Review study databases for incomplete/missing data and other data issues.
Oversee the activities of other DCC staff assigned to manage studies.
Reconcile discrepancies and obtains guidance when values are questionable or illegible.
Interact with clinical personnel to resolve omissions, discrepancies or any other data management issues.
Mentor junior Data Managers on standards, DM practices and Quality Assurance practices.
Generate, distribute, track, enter resolution, annotate and file data entry reconciliation reports and data clarifications.
Verify computer-generated output against original data.
Check work for accuracy on a daily basis according to established procedures.
Report any system/data errors and/or problems to their supervisor.
Assist clinical users in database interaction as necessary, performing queries upon supervisor's direction.
Adhere to a policy of strict confidentiality concerning all documents, data, and information maintained within the department.
Adhere to department Standard Operating Procedures for all data management responsibilities.




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 
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Clinical Data Manager Apply now