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Senior Manager/Associate Director, Clinical Data Management

Clinical Dynamix, Inc.

Watertown, MA

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JOB DETAILS
SKILLS
Acceptance Testing, Alliance/Partner Management, Best Practices, Biotech and Pharmaceutical, Budgeting, Clinical Data, Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Management, Clinical Trial, Code Reviews, Communication Skills, Contract Research Organization (CRO), Data Cleaning, Data Collection, Data Entry, Data Management, Data Quality, Data Visualization Tools, Electronic Data Capture (EDC), Information/Data Security (InfoSec), Interpersonal Skills, Medical Coding, Medical Dictionary for Regulatory Activities (MedDRA), Medical Terminology, Organizational Skills, Outsourcing, Procedure Development, Process Improvement, Quality Control, Quality Management, Relationship Management, Requirements Management, Standard Operating Procedures (SOP), Supplier Relationship Management (SRM), Technical Leadership, Vendor/Supplier Relations, World Health Organization Drug Reference List (WHODrug)
LOCATION
Watertown, MA
POSTED
1 day ago

Senior Manager/Associate Director, Clinical Data Management (Hybrid; Greater Boston, MA)

How you’ll make an impact:

  • Act as Lead Data Manager, overseeing all deliverables of activities outsourced to DM CRO for multiple studies
  • Interact and manage relationships with other functional areas to ensure high quality data management activities
  • Oversight of data collection tools (EDC, DTAs, EDC integrations) and essential documents (DMP, UAT Documents, data edit specifications, annotated case books and data entry guidelines)
  • Participate in User Acceptance Testing Activities for the applicable Data Collection Tools
  • Perform Quality Control for the data completeness and accuracy.
  • Participate in and support data cleaning, query generation and resolution and review of medical coding as needed.
  • Responsible for adhering to the Data Management timelines and budget.
  • Provide technical expertise to help in the use of technologies for Data Management and the clinical study team.
  • Contribute to the development of lessons learned and best practices as well as help develop SOPs and internal working procedures and process improvement initiatives.
  • Contribute to the establishment of systems and tools to help ensure clinical data security and integrity.

Skills and experience you’ll bring:

  • 8+ years’ experience in clinical data management in biotechnology or pharmaceutical industry, with outsourced CRO oversight experience
  • 5+ years managing vendor relationships/partnerships in a global environment.
  • Must have advanced knowledge of Data Management processes and systems
  • Solid understanding of CDISC standards required
  • Data Visualization Tool experience preferred.
  • Experience using standardized medical terminology, including but not limited to MedDRA and WHODrug.
  • Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a study team environment.

About the Company

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Clinical Dynamix, Inc.