Clinical Data Manager

Location
New York, NY, USA
Posted
Oct 09, 2020
Ref
192304
Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time
The Clinical Data Manager (CDM) is responsible for leading and overseeing all data management activities for in-house and outsourced clinical trials. The CDM must clearly demonstrate excellent organizational abilities. This position will include managing the technical aspects of data management systems and working with outside vendors.

Job Responsibilities:
  • Provide operational leadership of data management tasks for all MTEM-sponsored clinical trials from start-up to close-out (including but not limited to eCRF design & edit checks, data capture/completion guidelines, work instruction manuals, SOPs, UAT, project specific data management plans, data review & reporting, medical coding, data import/export, transformation to SDTM, database lock).
  • Ensure adequate documentation and application of internal and industry standards/best practices across studies.
  • Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data.
  • Generate data queries based on validation checks or errors and omissions identified during data entry to resolve identified problems
  • Oversee CROs and vendors for all data management related activities, providing consistent team direction/guidance and monitoring quality of work through key performance metrics.
  • Manage timelines for data management activities such as to planned data cuts, data transfers, database cleaning and freezing.
  • Represent Data Management at cross-functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks.
  • Participate in Data Management department infrastructure, by contributing to SOPs/work instructions development, CRF standards development and cross-functional process improvement initiatives.
  • Support Project Management and Contracts on DM budget-related activities.
  • Mentor other team members as applicable, and any other duties as assigned.
  • Evaluate processes and technologies, and suggest revisions to increase productivity and efficiency

Requirements:
  • Bachelor's degree in the scientific, life sciences, computer sciences, mathematics field or related field, required. Advanced degree is preferred.
  • Minimum of five years of Clinical Data Management and hands-on experience with SDTM programming in the pharma/biotech industry. Strong oncology trial experience preferred.
  • Extensive technical experience using EDC systems including Medidata RAVE.
  • Strong experience in CRO and vendor oversight with consistent track record of on-time quality deliverables.
  • In-depth knowledge of DM industry standards, best practices and CDISC implementation (CDASH, ODM, SDTM).
  • Ability to manage multiple priorities
  • Strong attention to detail
  • Proficient in Microsoft Office applications
  • Ability to communicate effectively in English
  • Ability to Travel: 5 %

Reporting Structure:

This position does not have supervisory responsibilities. This position reports to SVP, Clinical Operations.

Molecular Templates Inc https://mtem.isolvedhire.com