Position Objective: Provide services as a Clinical Advisor (Clinical Data Management) (Part-Time) in support of the overall functions of the Division of AIDS (DAIDS), Office for Policy in Clinical Research Operations (OPCRO) within the National Institute of Allergy and Infectious Diseases (NIAID).
Duties and Responsibilities:
- Provide data management expertise to federal leadership to oversee clinical data management project timelines on multiple complex clinical trials or programs.
- Provide technical advice and oversight of service providers performing core data management functions including; case report form (CRF)/edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures.
- Responsible for the oversight of clinical data management study deliverables, evaluates and mitigates risks across programs on behalf of the Division of AIDS.
- Conducts data reviews.
- Review the development of database specifications, validation plans, and data management plans, ensuring alignment with CRFs, protocol, and safety data standards.
- Participate in cross-functional data management-related process initiatives on behalf of the Division of AIDS.
- Responsible for helping oversee the end to end data management clinical trial related activities on a day to day basis, and is the ultimate accountable person for the data management study deliverables in terms of quality and delivery according to plan.
- Provide expertise and guidance to federal clients for the oversight of data management activities, including: 1) implementation of data management aspects of clinical protocols and data collection systems; 2) strategic input into proposal or protocol design focused on data management considerations; 3) mitigation of potential data management issues by reviewing protocols for cross-project consistency and identifying standard case report form modules to meet objectives; 4) reviewing data management activities and recommending process improvements; and 5) maintaining high-level oversight on data quality metrics and data management deliverables.
Basic Qualifications:
- MS degree required.
- Minimum of seven (7) years of clinical data management experience is required.
- Industry (contract research organization or sponsor) work experience required.
- Pharmaceutical company work experience required.
- Experience working with all phases of clinical trials is required.
Minimum Qualifications:
- Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
- Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.
GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.
This position is contingent upon contract award.
