Senior Manager Clinical Data Manager

Apply Now

Company: Katalyst HealthCares and Life Sciences

Location: Dallas, TX 75217

Description:

Responsibilities:
  • Leads a large clinical study or a series of related studies with minimal guidance.
  • Represents Data Management at study management team meetings.
  • Provides mentoring and training to lower-level Data Management staff assigned to his/her studies Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts.
  • Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
  • Performs a thoroughly detailed review of eCRF data requirements and create one if need be.
  • Interacts with CRAs, programmers, study operations lead and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
  • Leads the development of data edit check specifications and data listings.
  • Coordinates the design and testing of Electronic Data Capture (EDC) systems according to company processes.
  • Resolves EDC system issues with team members.
  • Develops or lead the development of the Data Management Plan for a clinical study.
  • Reviews and provides feedback to the clinical team on other study documents Statistical analysis plans and vendor specifications.
  • Provides training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed.
  • Performs reconciliation of data from external data sources against the clinical database.
  • Performs Serious Adverse Event reconciliation activities according to SOPs and guidelines.
  • Leads database upgrades/migrations including performing User Acceptance Testing.
  • Performs database lock and freeze activities per company SOPs.
  • Adheres to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.
  • Performs miscellaneous duties as assigned.
Requirements:
  • Master's degree with 7 years of experience or PhD with 4 years of experience, preferred.
  • Must have good project management skills and a proven ability to multitask.
  • Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. Possesses strong English language written and verbal communication skills.
  • Experience in working with oncology studies.
  • Able to travel to off-site meetings or training seminars as needed.
  • Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications.
  • Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.

Similar Jobs