Duties

Major duties include but are not limited to:

• Manages data capture, editing and transfer activities.
• Monitors timelines and ensures that clinical data management deadlines are met.
• Assists Center Validation Team to validate the data management system.
• Leads Data Validation and Quality Control Effort.
• Identifies and troubleshoots operational problems, issues, obstacles and barriers for clinical studies.
• Develops and Leads data management programming efforts for study setup.
• Develops and maintains enhancements of Quality Control Reporting and Patient Scheduling.
• Creates and maintains data management documentation for studies.
• Performs software application development to support various studies.
• Reviews and provides feedback on study protocols.
• Assists on the design and development of study Case Report Forms (CRF).
• Assists in the development of data management section of Study Operations Manual and instructions.
• Works as a liaison with in-house study team.
• Leads the training activities for the study site staff.
• Leads standardization efforts of the CDM functional group.
• Acts on behalf of CDM functional group leader for training of data management staff.
• Develops training tools and material for site personnel and clinical data managers.
• Provides leadership for cross-functional and organization wide initiatives

Work Schedule: Monday - Friday 8:00am - 4:30pm
Telework: VA supports the use of telework as a way to help attract and retain talented individuals in public service, increase worker productivity, and better prepare the agency to operate during emergencies. This position may be authorized for telework. Telework eligibility will be discussed during the interview process.
Virtual: This is a virtual position.
Position Description/PD#: Technical Information Specialist/PD13159-O
Relocation/Recruitment Incentives: Not Authorized
Permanent Change of Station (PCS): Not Authorized
Financial Disclosure Report: Not required

Requirements

Conditions of Employment

• You must be a U.S. Citizen to apply for this job
• Selective Service Registration is required for males born after 12/31/1959
• You may be required to serve a probationary period
• Subject to background/security investigation
• Selected applicants will be required to complete an online onboarding process
• Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP)
• Participation in the Coronavirus Disease 2019 (COVID-19) vaccination program is a requirement for all Veterans Health Administration Health Care Personnel (HCP) - See "Additional Information" below for details.

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 05/23/2022.

Time-In-Grade Requirement: Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-11 position you must have served 52 weeks at the GS-9. The grade may have been in any occupation, but must have been held in the Federal service. An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials. If the most recent SF-50 has an effective date within the past year, it may not clearly demonstrate you possess one-year time-in-grade, as required by the announcement. In this instance, you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade. Note: Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment.

You may qualify based on your experience and/or education as described below:

INDIVIDUAL OCCUPATIONAL REQUIREMENT (IOR): An IOR is a basic requirement that must be met in order to qualify for entry into this job series, and it is something that can't be waived. The education must be accredited by an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. To qualify for the GS 1412 occupational series, applicants MUST possess one of the following:

Basic Requirement: You must meet one of the following basic requirements.

Education: A full 4-year course of study that meets all the requirements for a bachelor's degree with major study in the subject-matter field of the position to be filled (e.g.,computer science, electrical engineering, database studies, big data, data analysis, etc.). (UNOFFICIAL TRANSCRIPT REQUIRED: If you do not submit your transcript, your application may not be reviewed.) OR, Experience: Four years of experience that provided a knowledge of the basic principles, theories, practices, techniques, and terminology of a discipline or subject-matter field; and an understanding of the standard methods, procedures, and techniques of research and analysis in the subject-matter field. Such experience must have been equivalent to that which would have been gained through a 4-year college curriculum. (This experience must be supported by your resume to be creditable.) OR, Combination: A combination of education and experience as described above. (UNOFFICIAL TRANSCRIPT AND/OR CLEAR DETAILS OF EXPERIENCE REQUIRED: If you do not submit the required document, your application may not be reviewed.)

In addition to meeting the basic requirements, applicants for GS-11 must have the amounts of education and/or experience required for the GS-11 grade level as shown below.

Grade GS-11: You must have 3 full years of progressively higher-level education or doctoral degree (Ph,D.,M.D., or equivalent) related to the position.

• Specialized Experience: Experience must have demonstrated the ability to perform, supervise, or direct one or more of the functional areas of work covered by this series; to understand the concepts, theories, new developments, and co-relationship of information in related fields; and to maintain up-to-date information on the state of the art. You must have one year of specialized experience equivalent to at least the next lower grade GS-9 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: managing data capture, editing, and transfer activities; validates data management systems; performs quality control checks and auditing for missing data; produces and distributes study site; identifies and troubleshoots operational problems, issues, obstacles, and barriers; develops and leads data management programming efforts; develops, test, maintains enhancements of Quality Control Reporting and Patient Scheduling; creates and revises data management documents; performs software application development. OR,
• Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have 3 full years of progressively higher-level graduate education or doctoral degree (Ph.D., M.D., or equivalent) related to the position? (UNOFFICIAL TRANSCRIPT REQUIRED: If you do not submit your transcript, your application may not be reviewed.). OR,
• Combination: Applicants may also combine education and experience to qualify at this level. You must have an combination of specialized experience and education beyond 3 full years of progressively higher-level graduate education or doctoral degree (Ph.D., M.D., or equivalent) related to the position. (UNOFFICIAL TRANSCRIPT REQUIRED: If you do not submit your transcript, your application may not be reviewed.)

You will be rated on the following Competencies for this position:

• Data Management
• Technical Competence
• Research
• Quality Management
• Database Management Systems
• Communications

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religions; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

Note: A full year of work is considered to be 35-40 hours of work per week. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment.

Physical Requirements: The work is sedentary. Typically, the employee may sit comfortably to perform portions of the work, however there is periodic walking, standing, bending, carrying of light items such as medical records, instructional material, books, and manuals. No specific physical demands are required to perform the work. Some travel will be required to attend study related meetings.

Work Environment: The work environment involves everyday risks or discomforts which require normal safety precautions typical of such places as offices, meeting and training rooms, libraries, and residences or commercial vehicles. The work area is adequately lighted, heated and conditioned.

For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/ .

Education

A transcript must be submitted with your application if you are basing all or part of your qualifications on education.

Note: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/ . If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html .

Additional information

The Career Transition Assistance Plan (CTAP) provide eligible displaced Federal/VA competitive service employees with selection priority over other candidates for competitive service vacancies. To be qualified you must submit appropriate documentation (a copy of the agency notice, your most recent performance rating, and your most recent SF-50 noting current position, grade level, and duty location) and be found well-qualified for this vacancy. To be well-qualified : applicants must possess experience that exceeds the minimum qualifications of the position including all selective factors, and who are proficient in most of the required competencies of the job. Information about ICTAP and CTAP eligibility is on OPM's Career Transition Resources website at http://www.opm.gov/policy-data-oversight/workforce-restructuring/employee-guide-to-career-transition/ .

This job opportunity announcement may be used to fill additional vacancies.

Pursuant to VHA Directive 1193.01, VHA health care personnel (HCP) are required to be fully vaccinated against COVID-19 subject to such accommodations as required by law (i.e., medical, religious or pregnancy). VHA HCPs do not include remote workers who only infrequently enter VHA locations. If selected, you will be required to be fully vaccinated against COVID-19 and submit documentation of proof of vaccination before your start date. The agency will provide additional information regarding what information or documentation will be needed and how you can request a legally required accommodation from this requirement using the reasonable accommodation process.

To ensure compliance with an applicable preliminary nationwide injunction, which may be supplemented, modified, or vacated, depending on the course of ongoing litigation, the Federal Government will take no action to implement or enforce the COVID-19 vaccination requirement pursuant to Executive Order 14043 on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees. Therefore, to the extent a VA job announcement includes language requiring applicants to be fully vaccinated against COVID-19 pursuant to Executive Order 14043, that requirement does not currently apply to this Job Announcement. VA may request information regarding your vaccination status, if selected, for the purposes of implementing other workplace safety protocols, such as masking, physical distancing, testing, travel, and quarantine.

Due to COVID-19, VA is currently in an expanded telework posture. If selected, you may be expected to temporarily telework, even if your home is located outside the local commuting area. Once employees are permitted to return to the office, you will be expected to report to the duty station listed on this announcement. Management officials will provide information about returning to the official, pre-pandemic worksite, when applicable. At that time, you may be eligible to request to continue to telework depending upon the terms of your organization's telework policy and the duties of the position.

If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application .