Clinical Data Manager

Viking Therapeutics; San Diego (CA); Presencial; USD 110.000 - 120.000; Jornada completa

Descripción de la vacante

Viking Therapeutics, Inc. is seeking a Clinical Data Manager to ensure timely conduct of data management activities for assigned studies in line with protocols, SOPs and regulatory requirements.

The role involves interacting with cross-functional teams and CROs, with title depending on experience. The position requires experience in data management, CRF design, EDC/IRT/ePRO, and data review plans, as well as strong communication and documentation skills.

Formación

• : Bachelor's degree or higher in a medical or scientific field.
• : 2+ years of experience in Clinical Data Management; 3+ years in a Clinical Data Manager role preferred.
• : Experience writing plans and technical specifications for Clinical Data Management.
• : Experience in clinical data entry system design, development, and maintenance.
• : Experience carrying out data review plans.
• : Experience managing multiple projects at once.
• : Preferred: Experience in Phase 3 clinical trials.
• : Strong analytical and problem-solving skills; excellent verbal and written communication.

Responsabilidades

• Oversee CRO Data Management counterparts for assigned studies
• Provide status updates on Data Management 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 CRF Completion Guidelines (CCG) to align with protocol requirements
• Manage the development and maintenance of data entry systems for clinical trials, including EDC, IRT, and 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 timely data review
• Partner with study team members in managing pre-lock activities and on-time database lock
• Collaborate across functional areas and CROs/vendors
• Identify and communicate risk to Data Management timelines and propose solutions
• Adhere to ICH, GxP, CDISC, 21 CFR Part 11, FDA guidelines
• Other duties as required

Conocimientos

Data Management

Verbal communication

Written communication

Attention to detail

Analytical skills

Microsoft Office

Educación

Bachelor's degree or higher in a medical or scientific field

Herramientas

EDC

IRT

ePRO

MS Office Suite

Descripción del empleo

Description

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.

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; elevate 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

Requirements

Education and Experience

• 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 managing multiple projects at once
• Experienced identifying issues and applying insightful problem-solving to propose solutions
• Preferred: Experience 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.

Salary Description

$110,000.00 - $120,000.00 annual salary