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.
Assist DIAN-TU 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 vendor, service providers, DIAN-TU Cores and statistical teams to ensure the accurate, efficient and compete data collection for DIAN-TU clinical trials.
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:
Oversight of the data management work conducted by the data management vendors.
Conducting SAE reconciliation for the studies under their responsibility and working with members of the SMT and US Drug Safety to resolve issues.
Ensures the Medical Teams have prompt, complete and clear status updates on the status of the data management deliverables for DIAN-TU clinical trials.
Provides data management input to trial design and protocol development.
Delivery of the Data Management Plan and associated components (including Biosample Management Plan, Data Validation Specifications, Data Quality Components and Data Review Plan).
Working with the data management vendor to quality assure the quality and quality control (QC) of the vendor deliverables. This incorporates UAT of the clinical database.
Proactively and collaboratively works with colleagues on the planned timing of the raw data and SDTM compliant data from the vendor database.
In collaboration with colleagues, supports delivery of tools and listings to support the Medical Teams and the SMTs in surfacing data (Patient Profiles, Data Listings etc.). The data manager may be required to generate a simple listing or report using a tool such as SAS, RAVE or Spotfire.
Collaborates closely with colleagues on the timing of data delivery for PBRERs and DSURs.
Ensures the archiving of all data management deliverables in eTMF in a timely basis.
As required, give presentations at senior management fora on the status of key projects or initiatives.
Staying abreast of internal and external developments (scientific, clinical, medical, commercial, competitive, legal, regulatory et al) which may impact the portfolio of data management work.
Supports the hiring of permanent data management staff and on-site consultants, as required.
Assists in on-boarding, coaching or mentoring new or less experienced team members, including on-site consultants.
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.
Bachelor’s degree required; prior work experience, preferably in clinical research support, is required; additional work experience in clinical research can substitute for required education; a combination of work and education equaling 4 years may substitute for this requirement.
Prefer a master’s degree 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 coordinating and/or CRA experience is beneficial.
Neurology and/or Alzheimer’s disease experience is highly desirable.
Significant clinical data management experience.
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.
Proven strategic agility, organizational and project management skills.
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. Must be 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.).
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).
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.
The hiring range for this position is $56,472 - $73,403 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.
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.