Kansas Works Veterans Jobs

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13158915 Primary Responsibilities

• Responsible for coordinating, facilitating, and participating in all data management activities from initiation of protocol, study startup through database lock with minimal oversight.
• Provide Data Management oversight for outsourced projects.
• Provide vendor management.
• Support CRF design, review, and validation of clinical database.
• Author and maintain all project start-up documents; including, but not limited to: eCRFs, eCRF Completion Guidelines, Data Management Plan, Edit Check Specifications
• Perform user acceptance testing for assigned projects.
• Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target with project timelines.
• Prepare data transfer agreements & coordinate the receipt of data transfers.
• Author all database lock documentation for assigned projects.
• Prepare all data cleaning and data status documentation; including, but not limited to: metric reports, custom reports, data review listings, reconciliation reports, clean patient tracker, etc.
• Performed ad-hoc reporting.
• Adverse event and concomitant medication coding using MedDRA and WHO-Drug.
• Responsible for SAE reconciliation.
• Provide data management timelines and cost associated in the project scope of work.
• Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed.
• Ability to support a number of moderate to complex trials with minimal supervision.
• Build successful relationships and seamless interfaces at the project team level and provide timely and effective communication to the study team, trial manager, and Biostatistics.
• Interface closely with Biostatistics and Project Management on the project level.
• Provide mentorship to junior level Data Mangers.
• Perform all activities in compliance with applicable regulations, internal policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
• Bring a \"can do\" spirit to work and deliver on other responsibilities as assigned.

Education or Certification Requirements

• Bachelor\'s degree in a related health profession or a field related to research compliance
• 5+ years of data management experience in a CRO or sponsor company environment

Professional Work Experience

• Knowledge of CDISC/CDASH standards
• Experience with EDC systems.
• Knowledge of medical terminology and use of coding dictionaries.
• Knowledge of ICH, FDA, and GCP regulations and guidelines related to data management.
• Applicable experience in biotech, pharmaceutical and/or medical device industries preferred.
• Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).

Qualifications and Skills

• Strong scientific background and understanding of clinical trials including pharmaceutical, device, operations, and regulatory compliance.
• Proven ability to take independent action to initiate process improvement, when needed.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

If you would like to complete our voluntary sel -identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Company Profile:

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com .