Principal Data Manager

Job Description

Description:

SUMMARY

The Principal 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 Principal Clinical Data Manager will interact internally and externally with cross-functional teams, including Clinical Operations, Clinical Safety, Biostatistics, and CROs.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The main responsibilities of this role include but are not limited to the following:

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

Serve as a knowledge matter expert in Clinical Data Management

Contribute to the training and development of staff within the Clinical Data Manager Department

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 Requirements:

EDUCATION AND EXPERIENCE

Minimum 8 years of experience in Clinical Data Management

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

Preferred: Experienced in Phase 3 clinical trials

KNOWLEDGE AND SKILLS

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

VIKING THERAPEUTICS

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Notice to Agency and Search Firm Representatives

Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Full-time

Hybrid remote