Scheduled Hours

40

Position Summary

Acts as DIAN-TU Clinical Data Management functional lead and assists Clinical Operations team with the data management process life cycle (e.g., CRF Design through Database Lock) in coordination with Contract Research Organizations (CROs), data management vendors, service providers, DIAN-TU cores and statistical teams to ensure the accurate, efficient and complete data collection for DIAN-TU clinical trials.

Job Description

• Responsible for project oversight of all data management activities for assigned studies.
• Primary contact for Contract Research Organizations (CROs) performing data management activities for assigned studies.
• Leads the development of clinical case report forms working in collaboration with the clinical project team, biostatistics, and other functional team leads as required.
• Coordinates the work of the assigned Clinical Data Coordinator.
• Assists the clinical project team with development of clinical case report forms.
• Assists data management vendors in database design; coordinating program development, testing, and User Acceptance Testing (UAT) of clinical databases prior to production.
• Critically reviews and maintains data management plans throughout the life-cycle of a study protocol including the development of data handling and data entry guidelines.
• Provides primary assistance in reviewing validation specifications for databases.
• Reviews electronic clinical data transfer specifications, ensures specifications, enables accurate and complete analysis in accordance with the clinical protocol.
• Tracks study progress relative to data queries, CRF pages received, data entered, etc. and issue periodic status reports to clinical project team.
• Assists with oversight of data management vendors in coding adverse events, concomitant medications, and medical history data.
• Actively participates on project team and present data management concerns; Coordinates regular Safety Review meetings, QC Review meetings, and other meetings as needed.
• Communicates project status and key project issues to project management team and all functional groups/cores as appropriate.
• Performs quality control/assurance tasks on database content/structure and data reports.
• Assists with development of procedures for ongoing/final data review and quality assurance processes.
• Leads and assists with the coordination of database locks and releases of data for analysis (through the data management vendor).
• Provides input for existing or new SOPs and other procedural documents; Development of SOPs and working practices relevant to regulatory sponsor oversight.
• Contributes to the processes for the standardization of data collection tools, formats and associated documentation (CRFs, e-CRFs, IVRS, hand-held diaries, etc.).
• Ensures the consistent implementation of procedures, data standards and data coding dictionaries across assigned studies.
• Provides input to vendor requests for information and contracts for outsourced work.
• Participates in review of invoicing for data management activities provided by the CRO vendor or other vendors as needed.
• Ensures project documentation is current on an ongoing basis and ensures that all Trial Master Filing is up to date.
• Participates in and/or assists with Investigator meetings.
• Provides input to problem-solving and implements corrective action plan when necessary.
• Maintains a good working knowledge of regulatory guidelines relevant to clinical data management (i.e., ICH/GCP and 21 CFR Part 11 Electronic Records and CDISC) and related SOPs.
• Assists Administration and Clinical Operations teams in planning, developing and integrating project objectives.
• Performs other related duties as assigned to meet departmental and project objectives.

Working Conditions
Job Location/Working Conditions

• Busy office environment with frequent moderate/high pressure caused by deadlines
• After-hours or weekend responsibility due to urgent situations and international duties
• Able to fly to various meetings (domestic and international) at investigator, pharma partner, trial, vendor or regulatory agency sites

Physical Effort

• Typically sitting at desk or table
• Repetitive wrist, hand, or finger movement

Equipment

• Office equipment

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications

Education:

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

Certifications:

No specific certification is required for this position.

Work Experience:

Relevant Experience (5 Years)

Skills:

Healthcare Environments, Life Science

Driver's License:

A driver's license is not required for this position.

More About This Job

Washington University seeks highly motivated individuals who are able to perform duties in a manner consistent with our core mission and guiding principles.

Preferred Qualifications

Education:

No additional education beyond what is stated in the Required Qualifications section.

Certifications:

No additional certification beyond what is stated in the Required Qualifications section.

Work Experience:

No additional work experience beyond what is stated in the Required Qualifications section.

Skills:

Clinical Research, Communication, Data Management, Drug Development, Leadership, Teamwork

Grade

G14

Salary Range

$75,200.00 - $128,800.00 / Annually

The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.

Questions

For frequently asked questions about the application process, please refer to our External Applicant FAQ.

Accommodation

If you are unable to use our online application system and would like an accommodation, please email [email protected] or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.

All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.

Pre-Employment Screening

All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.

Benefits Statement

Personal

• Up to 22 days of vacation, 10 recognized holidays, and sick time.

• Competitive health insurance packages with priority appointments and lower copays/coinsurance.

• Want to Live Near Your Work and/or improve your commute? Take advantage of our free Metro transit U-Pass for eligible employees. We also offer a forgivable home loan of up to $12,500 for closing costs and a down payment for homes in eligible neighborhoods.

• WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.

Wellness

• Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!

Family

• We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We’ve got you covered.

• WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.

For policies, detailed benefits, and eligibility, please visit: https://hr.wustl.edu/benefits/

EEO/AA Statement

Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University’s policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.

Diversity Statement

Washington University is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment – fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.