As of August 24, 2021, AmerisourceBergen requires all U.S. team members to be fully vaccinated and show proof of completed vaccine status at time of hire. If you cannot receive the COVID-19 vaccine due to a disability/medical reason or sincerely held religious belief you will be required to follow AmerisourceBergen’s policy and process to apply for an exemption/accommodation.

This is a remote role for US-based candidates.

The Assistant Director, Clinical Data Management is responsible for independently leading the clinical data management aspects of prospective clinical studies. The Assistant Director, Clinical Data Management has thorough knowledge of FDA regulations and industry standards, strong technical skills, and can work collaboratively with team members to assure that data management functions are performed in compliance with regulations and according to study protocol.

PRIMARY DUTIES AND RESPONSIBILITIES:

The responsibilities of the Assistant Director, Clinical Data Management may include, but are not limited to the following:

• • Accountable for oversight of all data management deliverables including accurate and reliable data in accordance with protocols for multiple studies.
  • Subject Matter Expert in data management processes and multiple clinical data management systems
  • Designs case report forms (CRFs) and associated annotated CRFs in accordance with the final study protocol
  • Builds eCRFs independently using selected EDC platform in accordance with industry standards (e.g. CDISC, STDM, HITECH Act, 21CFR Part 11,etc)
  • Develops specifications for receipt of external data, data validation/review, medical coding, query management and SAE reconciliation
  • Develops/executes/reviews project documentation, including, but not limited to, Data Management Plan, Quality Review Plan, eCRF Completion Guidelines, edit checks, query logic and work instructions
  • Develops user acceptance testing (UAT) specifications and testing plans in support of EDC deployment. Ensures all documentation is in place prior to EDC deployment
  • Works with the study analyst to develop statistical analysis plans (SAP), tables, listings, and figures (TLF)
  • Reviews and correctly interprets analysis output for accuracy and presentation to Sponsors
  • Responsible for maintaining Data Management component of Trial Master File
  • Creates export specifications and leads data reconciliation and linking of electronic data transfers from all study data sources
  • Ensure that the data collected conforms to the highest data quality and accuracy
  • Trains and initiates investigative sites on data collection procedures and EDC system requirements
  • Ensures adherence to protocol, ICH, GCPs, SOPs
  • Contributes to the development and/or revision of Clinical Data Management SOPs and related documentation
  • Actively looks for and promotes process improvement opportunities and adopts an innovative mindset

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

• • Bachelor’s degree in life-sciences or related field (post graduate degree preferred)
  • Minimum of 8 years of broad and hands-on clinical data management experience
  • Experience of hand-on data building, testing and deployment of e-CRFs using various EDC platforms
  • Strong understanding of clinical trial process and EDC platforms
  • Preferred Clinical Data Manager certification (CCDM)
  • Preferred SAS programming skills
  • Strong working knowledge of GCPs and Federal Regulations
  • High level of organization and self-motivated to manage multiples studies simultaneously
  • Proficiency in MS Word, MS Excel, MS PowerPoint
  • Understanding of medical term coding concepts (WHO, MedDRA)
  • Understanding of basic statistical concepts
  • Excellent written and oral communication skills

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

Possesses and applies comprehensive knowledge of particular field of specialization to the completion of significant assignments. May cross fields.
• Broad technical knowledge of outcomes research and health economics
• Structured and well organized
• Excellent writing skills as well as the ability to communicate complex material in presentations and discussions in a straightforward manner
• Ability to work well in a dynamic, successful consulting firm, which maintains high quality standards and demands excellence
• Database management and analytical and statistical skills
• Economic modeling skills
• Medical writing skills
• Experience developing outcomes research/health economics study protocols
• Proficiency in Microsoft Office Suite
• Strong clinical skills preferred
• Strong work ethic

#LI-REMOTE

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What AmerisourceBergen offers

We offer competitive total rewards compensation. Our commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.

Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit.

Schedule

Full time

*This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.

Affiliated Companies:

Affiliated Companies: Xcenda, LLC

Equal Employment Opportunity

AmerisourceBergen is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.