Clinical Data Manager

Job Description :

POSITION – CLINICAL DATA MANAGER

The Clinical Data Manager is an experienced Data Management professional who has worked within a Pharmaceutical or CRO company.

JOB ROLE & RESPONSBILITIES:

Manage CDM activities including Medical Coding, Data Validation Checks, and Database Snapshot

Manage communication with eCRF/database vendors on consistent basis to address clinical team requests and/or eCRF development activities

Provide Clinical Data Management support to cross-functional team

Participate in the review of Clinical Research documents (Protocols and CRS) as needed

Manage and participate in UAT of eCRF build and validation documents, included but not limited to edit check document, issue logs and UAT summary report

Develops/executes/reviews project documentation including but not limited to, data management plan, eCRF Completion Guidelines, Edit Check, Query Logic, UAT, and work instructions for assigned projects

Ensure the quality of clinical data to support study report, IND and NDA submissions meets standards

Manage Study Start-Up: work across several studies to ensure all required documentation is in place in order to authorize sites for study enrollment

Manage and participate in study-specific meetings, teleconferences and training

Collaborate with cross-functional team members and study sites throughout all studies; and

Lead one or more studies at a client.

DESIRED SKILLS & EXPERIENCE

Associate’s degree in computer science, statistics, or equivalent a plus;

Experience with one or more of the leading CDM software applications, e.g., Oracle Clinical, InForm, etc. is required

Minimum 1 year of project lead/project management experience managing projects and/or staff

Experience and knowledge of the drug development process desired

Experience in a clinical development environment

Self-starter who is able to work independently and willing to provide original thinking

Successful team player with good interpersonal, oral and written communication skills