Senior Clinical Data Manager Consultant-(Cardiovascular)-Remote

ClinChoice

6h • Remote

About The Position

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Senior Clinical Data Manager Consultant to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Job Summary:
This role will be providing general DM support role tasks. Perform EDC validation UAT, data lsitings review, data issues tracking and query management, external data reconciliation, data listings review coordination. Here are some JD listed below:

Requirements

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Computer Science, or a related field.
• 5+ years of experience in clinical data management.
• Experience in Cardiovascular required.
• Strong knowledge of clinical trial processes, regulatory requirements, and
• Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault, etc.).
• Excellent communication, problem-solving, and leadership skills.

Responsibilities

• Perform EDC (electronic data capture system) build validation and update supporting documentations, included but not limited to: eCRF design specification, edit check documents, UAT test/issue logs, and UAT summary report.
• Assist oversight of EDC users and other Clinical databases user access management, including but not limited to, compiling master user lists and reviewing appropriate activating/deactivating user accounts.
• Accountable for on-time and comprehensive review of clinical study data listings
• Oversees and/or performs the reconciliation of key data points collected in EDC with other sources such as the Safety Database and Third Party/External Data Vendor systems.
• Support the design and testing of technical CDM components including eCRFs, Edit Checks, reports, and listings.
• Manages the effective communication of data issues and discrepancies to study sites via the query management process.
• Escalates relevant issues to lead data manager and appropriate study team as needed to facilitate timely resolution. Investigates and analyzes possible solutions using experience, judgement and precedent, has autonomy to propose alternatives and exercises judgement based on experience.
• Experience managing study-level data management activities and working with external vendors.
• Familiarity with clinical data systems (e.g., Medidata RAVE, Oracle Clinical, Veeva) and industry data standards (e.g., CDISC, SDTM).

What This Job Offers

• Career Level: Mid Level