Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location:
This position is in the Department of Neurology. The position is located at 4488 Forest Park. This position is for the Medical School Campus.
The Clinical Trial Manager supports and assists in the operational planning, management and execution of multiple phase II/III international trials for the Dominantly Inherited Alzheimer Network Trials 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.
The DIAN-TU is the regulatory sponsor and coordinating center for major drug trials for the prevention of Alzheimer’s disease. The DIAN-TU, including the DIAN-TU Trials, is funded through a partnership between Washington University, the Alzheimer’s Association, pharmaceutical companies, the National Institute on Aging, in addition to various other funding sources. Washington University DIAN-TU will serve as the regulatory sponsor and FDA IND holder for the trial(s).
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 prepare project tracking system with current trial(s) status and provide 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.
Bachelor’s degree in related field or equivalent level of training and experience.
Minimum of 1-2 years’ experience in clinical research.
SOCRA or ACRP certification required within 12 months of hire and/or when eligible.
Master’s degree preferred in business or healthcare.
Previous supervisory experience may be helpful.
5 to 10 years’ experience in clinical operation, preferably at a pharmaceutical, biotechnology company or CRO.
Experience managing FDA-regulated phase II and III therapeutic intervention trials is strongly preferred.
Global experience is desirable.
Prior Clinical Trial Management, Clinical Project Management and/or Clinical Research Associate experience is highly beneficial.
Neurology and/or Alzheimer’s disease experience is highly desirable.
Minimum of 5+ years’ experience in clinical research, project/program, and vendor 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.
Strong leadership abilities
Willing to travel as necessary (i.e. investigator meetings, seminars or company meetings, etc.)
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.
Proficient in Microsoft Office programs (Word, Excel, PowerPoint, Project, Publisher, Access, and Outlook).
Must possess 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.
Applicant Special Instructions:
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.
The hiring range for this position is $71,323 - $92,789 annually.
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. Current employees applying for a new position within the university may be subject to this requirement. The screenings will include a criminal background check and, as applicable for the position, other background checks, drug screen, 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.
Please attach a copy of your most current signed performance evaluation (completed within the last 18 months) to your online account. If you have not received a performance evaluation, you may provide two current signed letters of recommendation (written within the last 18 months), preferably to include one letter from either a current or recent former supervisor. To attach these documents, go to: My Career Tools, Add Attachment, Attachment Type – Performance Reviews or Letters of Recommendation.
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