Manager Clinical Trials - Neurology

Position Summary
Work completely REMOTELY or on a HYBRID office/home schedule! This is your opportunity to get involved in the effort to end/prevent Alzheimer’s disease and be a part of a top-notch, collegial team dedicated to leading the field. Our growing team needs your clinical trial management skills, working on a platform study with our partners in Australia, Europe, Asia, South America, and North America. Please read more about the cutting-edge research you can be a part of at the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) at Washington University School of Medicine in St. Louis, ranked #11 in research funding by U.S. News & World Report’s Best Medical Schools list (2022).
About DIAN-TU
Dominantly Inherited Alzheimer Disease (DIAD) is a rare form of Alzheimer’s disease that causes memory loss and dementia in people typically in their 30s to 50s. The disease affects less than 1% of the total population. In families that carry dominant mutations for Alzheimer’s, doctors can predict who will develop the disease and at approximately what age. This allows researchers to look for brain changes – long before symptoms appear – in people who carry such mutations, compared with their relatives who don’t.
At the DIAN-TU, we serve as the trial sponsor and we are evaluating promising drugs to treat DIAD. Through the DIAN-TU in 2012, our researchers initiated the world’s first Alzheimer’s disease prevention trial in DIAD families. Visit our website to watch videos about our trials and participant families (https://dian.wustl.edu).

Job Description

Primary Duties and 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), and pharmacovigilance.
• Facilitate and oversee all national level regulatory filings for the trial(s).
• Collaborate with all relevant groups: multiple pharmaceutical partners; Project Arm Leaders; the DIAN-TU Trial Cores: Biomarker, Biostatistics, Clinical, Cognition, Genetics, Imaging; Trial Project Leaders; CRO(s); vendor(s); investigational sites, and 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.
• Maintains all documents related to the project and uploads documents to the appropriate location for maintenance and storage.
• Escalate issues as appropriate for medical monitoring, safety, and exemptions/deviations, trial-wide GCP compliance at the sponsor, vendor, and site level, etc.
• Development of SOPs and working practices relevant to regulatory sponsor oversight.
• 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.
• Coordinate regular meetings with study team members and cores as appropriate for the project.
• Disseminates clinical project communication to all functional groups/cores as appropriate.
• Provides input to problem-solving and implements corrective action plan when necessary.
• Partners with applicable cores and/or CRO/vendor for resolution of corrective actions as a result of QA audit and/or regulatory inspections.
• 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.
• Planning and participation in investigator meeting(s) in collaboration with all cross-functional team members.
• Ensure training of Project Arm Leaders, all clinical trial sites, vendors, and DIAN-TU Cores on the protocol and expectations of the trial(s).
• 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.

Job Location/Working Conditions

Very busy office environment with frequent moderate/high pressure caused by deadlines. After hours and/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.

Preferred Qualifications

• Master’s degree in business or healthcare. 
• 5 to 10 years’ experience in clinical operation, preferably at a pharmaceutical, biotechnology company or CRO.
• Previous supervisory experience may be helpful.
• Experience managing FDA-regulated phase II and III therapeutic intervention trials is strongly preferred. 
• Global experience is desirable. 
• Prior coordinating and/or CRA experience is beneficial.
• Neurology and/or Alzheimer’s disease experience is highly desirable.
• Extensive direct clinical trial work experience in industry-regulated environment.
• Experience at a CRO and/or pharmaceutical environment strongly preferred.
• High degree of diplomacy and professionalism in handling confidential information and maintaining productive relationships with CCS personnel, other WUMC personnel, external sponsors and other customers. 
• Independent judgement and decision-making a must in planning and executing programs and supervising/advising others.
• Minimum of 5+ years’ experience in clinical research, project/program, and vendor and management.
• Experience in clinical trial start-up, maintenance and close-out.
• CRA, CRC, or PM experience in protocol development (trial design) and a strong understanding of the operational execution of clinical protocols from a sponsor perspective.
• Good comprehension of drug development and clinical trial methodology.
• Proficient in ICH/GCP and industry-regulated IND trial requirements and an ability to assess compliance to these guidelines.
• Ability to organize and manage multiple vendors participating in clinical studies.
• Superior organizational and negotiation skills.
• Strong leadership abilities.
• Ability to prioritize work effectively to meet timelines. Flexible with the ability to rapidly and effectively respond to changing priorities.
• Willing to travel as necessary (i.e., investigator meetings, seminars or company meetings, etc.)
• Ability to effectively work in a team environment and be flexible to contribute to the needs of the team.
• Skillful communication - clear, direct, and tactful communication skills.
• Basic business and medical writing skills required for pharma and site communication; protocol and amendment writing or review; study summaries; and progress reports.
• Budget Management - ability to develop a trial budget to monitor and control expenditures; provides justification/rationale for budget variances.
• Demonstrates basic presentation skills at Investigator or team meetings.
• Analytical skills - ability to identify trial-related, CRO-related or site-related issues, determines the causes and possible solutions to the problem.
• Good judgment, professionalism and independence are needed in interfacing with staff, CROs, pharma partners, subject matter experts / thought leaders, study coordinators, and investigators.
• Technical Competency - displays in-depth knowledge of clinical study procedures and maintains an awareness of environment as it affects clinical trial execution.
• Proficient in Microsoft Office programs (Word, Excel, PowerPoint, Project, Publisher, Access, and Outlook.

Required Qualifications

• Bachelor’s degree in related field or equivalent level of training and experience.
• Minimum of 1-2 years’ experience in clinical research.

Grade
G14

Salary Range
$73,700.00 - $125,900.00 / 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.

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.

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.