Clinical Data Manager

Viking Therapeutics, Inc.•San Diego, CA

2d•$110,000 - $120,000

About The Position

The Clinical Data Manager will ensure timely conduct of Clinical Data Management activities for assigned studies according to protocols, industry standards and guidelines, Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. The Clinical Data Manager will interact internally and externally with cross-functional teams, including Clinical Operations, Clinical Safety, Biostatistics, and CROs. Exact title (Clinical Data Manager I, Clinical Data Manager II, or Senior Clinical Data Manager) will depend on experience and skill level.

Requirements

Minimum of 2 years of experience in Clinical Data Management (>3 years experience with .2 years in Clinical Data Manager role preferred)
Bachelor's degree or higher in a medical or scientific field
Experienced verbal and written communication skills, including experience writing plans and technical specifications for Clinical Data Management
Experienced in clinical data entry system design, development, and maintenance
Experienced in carrying out data review plans
Experienced in managing multiple projects at once
Experienced identifying issues and applying insightful problem-solving to propose solutions
High degree of proficiency Microsoft Office Suite, file sharing software, and online conferencing applications
Strong analytical and problem-solving skills
Strong verbal and written communication skills
Excellent professional interpersonal skills with the ability to work in a positive and collaborative fashion
Ability to manage multiple tasks at once and maintain strong attention to detail
Self-motivated, dependable individual with self-confidence and a positive attitude

Nice To Haves

Experience in Phase 3 clinical trials

Responsibilities

Oversee CRO Data Management counterparts for assigned studies
Provide status updates on Data Management study responsibilities to internal team, including metrics and progress on deliverables
Ensure the development of high-quality study documentation from CROs for clinical trial data collection, handling, processing, quality control, and archival, including Data Management Plans (DMP)
Facilitate filing of study Data Management documents in the sponsor Trial Master File (TMF)
Establish optimal design of Case Report Forms (CRF) and corresponding CRF Completion Guidelines (CCG) to align with protocol requirements, meet trial oversight needs, and result in datasets suitable for analysis
Manage the development and maintenance of data entry systems for clinical trials, including Electronic Data Capture (EDC), Interactive Response Technology (IRT), and Electronic Patient-Reported Outcomes (ePRO)
Develop data review strategies, processes, and specific checks for assigned studies
Coordinate timely data transfers including development of Data Transfer Agreements (DTAs)
Monitor and contribute to data review processes to verify that timely and proficient data review is being carried out
Partner with study team members in managing the completion of pre-lock activities and ensuring on-time database lock
Collaborate across functional areas including Clinical Operations, Clinical Safety, and Biostatistics, both internally and externally with CROs and vendors
Identify and communicate risk to Data Management components of clinical trials; escalate risk to timelines as appropriate and provide insight and propose solutions
Adhere to Clinical Data Management internal standards as well as industry standards and regulatory requirements, including ICH guidelines, Good Practice guidelines (GxP), CDISC standards, 21 CFR Part 11, and FDA guidelines
Other duties as required