Clinical Data Manager I

Calyx•US MA Decentralized, MA

6d•$52,520 - $75,028•Remote

About The Position

The Clinical Data Manager is responsible for the delivery of an entire clinical trial. This role is sponsor-facing and works with study project management and the technical data management team to meet design specifications, monitor the health of the trial, ensure quality, and perform data reconciliation. The company, Perceptive, aims to shape the future of clinical research by helping the global biopharmaceutical industry bring new medical treatments to market faster. They emphasize a collaborative team environment where employees learn, grow, and win together.

Requirements

Understanding of study implementation and data collection requirements.
Ability to collaborate with project teams.
Ability to develop study-specific edit check criteria.
Ability to define, run, and review edit checks and resolve discrepant data.
Ability to maintain organized, complete, and up-to-date study documentation.
Ability to perform study setup, specifications, and obtain approvals.
Ability to coordinate and document the receipt and processing of electronic or ancillary data.
Ability to keep supervisor informed of project status.
Ability to review data and identify errors/inconsistencies.
Ability to collaborate with project teams to resolve data issues.
Ability to track outstanding issues and follow up until resolution.
Ability to ensure accuracy in manipulation and scrutiny of clinical data.
Ability to ensure CDM activities are carried out according to regulatory guidelines.

Nice To Haves

Candidates located in AZ, CT, DE, FL, GA, IL, MA, MO, NH, NJ, NC, PA, UT, VA are preferred.

Responsibilities

Ensures clinical trial databases meet project requirements by attending and participating in sponsor meetings.
Manages all data management deliverables for assigned studies.
Ensures the plan for data management is properly executed by understanding study implementation and data collection requirements.
Collaborates with the project team to develop study-specific edit check criteria.
Defines, runs, and reviews edit checks and resolves discrepant data.
Maintains organized, complete, and up-to-date study documentation.
Performs study setup, specifications, and obtains approvals as needed.
Coordinates and documents the receipt and processing of electronic or ancillary data from outside sources (e.g., data from other central laboratories, CRO's, or Sponsors).
Keeps supervisor informed of project status.
Ensures the accuracy and consistency of clinical databases by reviewing data and identifying errors/inconsistencies.
Collaborates with the appropriate project team to resolve data issues.
Tracks outstanding issues and follows up until resolution.
Ensures accuracy in manipulation and scrutiny of clinical data and that CDM activities are carried out according to regulatory guidelines.
Performs other duties as assigned.