Position Details

Position Information

Posting NumberS00427P
Position TitleClinical Data Manager
DepartmentRTRN/Data Coordinating Center
FLSA
Salary$40,000
Grant Funded Yes
LocationMS e-Center
Faculty or StaffStaff
Number of Vacancies1
Desired start date05/04/2015
Position SummaryThis position for the RTRN/Data Coordinating Center will serve as the Clinical Data Manager (CDM) on clinical projects from study start-up to database lock & freeze

Qualifications

Minimum Required EducationBachelor’s degree in related field (Public Health, Life Sciences, Computer Science, etc.)
Minimum Required Experience• Three (3) years in pharmaceutical/biotech, CRO or academic setting. Global/international experience preferred.

• Experience writing/drafting Data Management Plans, Validation Plans, and Case Report Form designs.

• Database experience (Oracle RDC, REDCap, CTMS, ARGUS, JReview, etc).

• Computer proficiency in Microsoft Word, Excel, PowerPoint, etc.)

• Coding {MedDRA, WHO Drug and ICD-9 or 10 experience is preferred. Experience with the i2b2 data model and its implementation.

• Experience in supporting large-scale cooperative clinical research projects.

• Knowledge of Good Clinical Practices (GCPs), ICH guidelines, and FDA regulations.

• Experience in writing scientific documents (grant proposals, NIH progress reports, SOPs, manuscripts, etc).

• Supervisory experience.

Minimum Required Licenses and/or CertificationsNone
Preferred Qualifications None
Skills and Abilities Skills & Abilities:
• Ability to work independently, as well as in a team environment.• Ability to explain in laymen’s terms the use of computer related technologies.

• Self-motivated and direct, with the ability to effectively prioritize and execute tasks in a high-pressure environment.

• Strong interpersonal skills.

• Capability to work on multiple projects simultaneously.

• Ability to complete deliverables on time and adjust priorities.

• Ability to work independently as well as collaboratively in a team environment.

• Proficient in the English language (both spoken and written).

• Excellent attention to detail and problem solving skills.

Responsibilities:
• Serve as the Clinical Data Manager (CDM) on clinical projects from study start-up to database lock and freeze.

• Creation of Case Report Forms (CRFs), completion guidelines, data entry guidelines.

• Facilitate training (OC, REDCap, ARGUS, CRF completion, etc).

• Creation of Data Validation Plan (DVP), Data Management Plan {DMP) and sections of the Manual of Procedures (MOP).

• Participate in and coordinate the User Acceptance Testing (UAT) of eCRF build using validation documents; these activities include but are not limited to: creating the edit check document, issue logs, and UAT summary report.

• Responsible for executing and/or overseeing data cleaning activities [i.e.,generating and managing database discrepancies, concomitant medications, adverse events (AEs) and reconciling serious adverse events (SAEs)].

• Tracking data status and timelines for reporting.

• Coordinate the archiving of study databases and related documents on the Workspace.
Participate in Standard Operating Procedure (SOP) review, development, and training.

Posting Detail Information

EEO Statement Jackson State University is an Equal Opportunity Employer. All application for faculty, staff, and student work-aid positions are considered without regard to race, sex, religion, national origin, disability status or protected veteran status. In addition, Jackson State University recruits, admits and provides services, financial aid, and instruction to all students without regard to race, sex, religion, national origin, age, disability status, veteran status or any other characteristic protected by law.
Background Check StatementJackson State University is committed to providing a safe campus. JSU conducts background checks for applicants being considered for employment. Background checks include reference checks, criminal history/record check and when appropriate a credit report or driving history report.
Open Date03/26/2015
Close Date
Open Until Filled (overrides close field) Yes
Special Instructions to Applicants