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/Aging and Dementia/DIAN-TU. This position is for the Medical School Campus.
Responsible for the operational planning and execution of multiple Phase II - III global/international studies, according to ICH-GCP and required regional regulations as applicable from protocol concept through the clinical study report. Ensures completion of study deliverables; develops Therapeutic Areas knowledge and expertise through internal training and external conference attendance. Responsible for the overall management of assigned study conduct, including oversight of the CRO and Trial Project Leaders.
PRIMARY DUTIES AND RESPONSIBILITIES:
Manage full scope of study conduct in collaboration with Administrative Operations to ensure studies are conducted according to the Code of federal Regulations, Good Clinical Practices, ICH Guidelines, local regulatory requirements and WU SOPs.
Collaborates with all relevant groups (Trial pharmaceutical partners, Project Arm Leaders, Administrative and Clinical Operations, Cores/Components, CRO, vendors, performance sites) to develop and manage clinical project timelines.
Coordinates meetings with study team members as appropriate for the project.
Disseminates clinical project communication to all functional groups as appropriate.
Contributes to protocol synopsis development and Clinical Operations feasibility assessments.
Writing of study protocols, amendments and administrative changes based on approved protocol synopsis, in collaboration with trial pharmaceutical partners, Project Arm Leaders and Clinical Operations.
Participation in the selection of CRO and all clinical vendors and cores/components (biomarkers, imaging, data management) for assigned studies.
Provides oversight of vendors/subcontracts (biomarkers, imaging, data management) which includes communicating expectations and timelines, ensuring deliverables are on time, with no quality issues.
Identify resource issues and escalate to DIAN-TU PI/Director, Deputy Director, Clinical Operations Director and/or Administrative Director.
Planning and participation in investigator meetings in collaboration with all cross-functional team members.
Ensure training of Project Arm Leaders, CRO, vendors, all performance sites and DIAN-TU Cores/Components on the protocol and expectations of the study.
Responsible for identifying vendor, CRO, performance site, Project Leader, and/or collaborator issues and bringing to the attention of the DIAN-TU PI/Director, Deputy Director, Medical Director, Clinical Operations Director and/or Administrative Director for discussion.
Provides input to problem-solving and implements corrective action plan when necessary.
Partners with Administrative and Clinical Operations personnel, Project Arm Leaders and CRO, where applicable, to resolve performance site issues.
Partners with Administrative and Clinical Operations personnel, Project Arm Leaders and CRO and/or vendors (biomarkers, imaging, data management) for resolution of corrective actions as a result of QA audit and/or regulatory inspections.
Escalate issues relevant to medical personnel as appropriate for medical monitoring, safety, and exemptions/deviations.
Manages timelines and maintain project tracking system with current study status and provide accurate progress reports on assigned studies as requested.
Collaborate with pharmaceutical partners to ensure appropriate and timely drug supply for assigned studies.
Maintains all documents related to the project and uploads documents to the appropriate location for maintenance and storage.
Review and input to Clinical Study Report.
Bachelor's degree or RN required.
Minimum of 5+ years’ experience in clinical research and program management including leadership and management experience.
MS, PharmD, or PhD preferred – preferably in a scientific discipline.
Experience in implementation and project management in a clinical setting is desirable.
CRA experience and practical experience in protocol development (study design) and a good understanding of the operational execution of clinical protocols.
Good comprehension of drug development and clinical trial methodology.
Good understanding of GCP/ICH/FDA requirements and an ability to assess compliance to these guidelines.
Willing to travel as necessary (i.e. investigator meetings, seminars or company meetings etc).
Must exercise good judgment to maintain confidentiality and ensure integrity of data.
Must work effectively in a team environment and be flexible to contribute to the needs of the group
Knowledge and Skills Communication skills- ability to be clear, direct, and tactful when communicating.
Basic business and medical writing skills required for protocols amendments, study summaries, and progress reports.
Ability to organize and manage multiple vendors participating in clinical studies.
Ability to prioritize work effectively to meet timelines.
Budget Management - ability to develop a study 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 study-related, CRO-related or site-related issues, determines the causes and possible solutions to the problem.
Responsible for resolving issues with study conduct with appropriate staff and CRO for a clinical study.
Good judgment, professionalism and independence are needed in interfacing with staff, CROs, Project 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 study execution.
Ability to provide input to managing external vendor resources (biomarkers, imaging, data management) related to study conduct.
Applicant Special Instructions:
Able to fly to various meetings at investigator, sponsor, performance, vendor or regulatory agency sites.
Some international travel will be required.
Base pay commensurate with experience.
Offers made for this position are contingent upon the successful completion of all required pre-employment screens, including a criminal background check, hair sample drug screen, and verification of required professional licenses, registrations, or certifications.
-Retirement Savings Plan -22 vacation days -8 Paid Holidays -Sick Time -Tuition benefits for employee, spouse and dependent children -Free Metro Link/ Bus pass -Free Life Insurance -Health, Dental, Vision -Health Savings Accounts (HSA) -Long Term Disability Insurance -Flex Spending Plan -Other Benefits
Med School HR website (medschoolhr.wustl.edu)
Internal Applicant Instruction:
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.
Washington University in St. Louis, a medium-sized, independent university, is dedicated to challenging its faculty and students alike to seek new knowledge and greater understanding of an ever-changing, multicultural world. The University offers more than 90 programs and almost 1,500 courses leading to bachelor's, master's and doctoral degrees in a broad spectrum of traditional and interdisciplinary fields, with additional opportunities for minor concentrations and individualized programs. The faculty is composed of scholars, scientists, artists and members of the learned professions. They serve society by teaching; by adding to the store of human art, creativity, understanding, and wisdom; and by providing direct services, such as health care.