Manager Clinical Trials - Neurology

Scheduled Hours

40

Position Summary

This position supports and assists in the operational planning, management and execution of multiple phase II/III international trials for the Dominantly Inherited Alzheimer Network Trial Unit (DIAN-TU) conducted in accordance with ICH/GCP and local regional requirements from protocol concept through clinical study report. This position contributes to the development of trial-related scopes of work, costs, timelines, metrics, and deliverables. This position will ensure the completion of study deliverables, milestones and objectives through management of assigned study conduct including oversight of trial CROs and vendors,

coordination of internal team and core members and/or external

vendors, and providing support to trial teams.

Job Description

Primary Duties & Responsibilities:

• Management and oversight of CROs and vendors including, but not limited to:
• Data management (EDC)
• Central lab
• Central read (MRI, ECG, etc.)
• IVRS/IWR
• Home health nursing network
• Clinical supplies packaging
• Global CRO (project management, monitoring, regulatory affairs)
• Pharmacovigilance
• Collaborate with all relevant groups:
• Multiple pharmaceutical partners
• Project Arm Leaders
• DIAN-TU Trial Cores: Biomarker, Biostatistics, Clinical, Cognition, Genetics, Imaging
• Trial Project Leaders
• CRO(s)
• Vendor(s)
• Investigational sites
• Subject matter experts to develop and manage clinical project timelines.
• Support full scope of study conduct (Clinical Operations) in collaboration with Administrative Operations to ensure the trial(s) are implemented and conducted according to the Code of Federal Regulations, Good Clinical Practices, ICH Guidelines, local regulatory requirements and WU SOPs.
• Manages to and within timeline and prepares project tracking system with current trial(s) status and provides accurate progress reports on assigned trial(s) as requested.
• Contribute to implementation of quality oversight measures and processes for all areas of the trial(s). Identification of trial issues or quality issues for escalation and remediation.
• Contribute to protocol and amendment development and Clinical Operations feasibility assessments.
• Collaborate with pharma partners to ensure appropriate and timely drug supply for assigned trial(s), including oversight of expiry, quantities, etc.
• Participation in the selection of CRO and all clinical vendors/components (biomarkers, imaging, data management) for assigned trial(s).
• Partners with CRO and/or applicable team for resolution of recruitment and site performance issues.
• Planning and participation in investigator meeting(s) in collaboration with all cross-functional team members.
• Performs other duties as assigned.
  

Working Conditions:

Job Location/Working Conditions

• Normal office environment
  
  

Physical Effort

• Typically sitting at desk or table
• Repetitive wrist, hand or finger movement (PC Typing)
  
  

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.

Education:

Required Qualifications

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:

Clinical Research (1 Year)

Skills:

Not Applicable

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.

Education:

Preferred Qualifications

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

Certifications:

Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP), Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA), Clinical Research Associate (CRA) - Association of Clinical Research Professionals (ACRP), Clinical Research Professional (CRP) - Association of Clinical Research Professionals (ACRP)

Work Experience:

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

Skills:

Clinical Project Management, Clinical Systems, Clinical Trials Administration, Computer Literacy, Deadline Management, Interpersonal Relationships, Leadership, Microsoft Excel, Microsoft Word, Oral Communications, Prioritization, SQL Databases, Stress Management, Written Communication

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 CandidateQuestions@wustl.edu 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.
• Take advantage of our free Metro transit U-Pass for eligible employees.
• 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.