Senior Manager, Clinical Data Management

Dormont Manufacturing Co; Redwood City (CA); Presencial; USD 170.550 - 200.700; Jornada completa

Descripción de la vacante

Corcept Therapeutics, based in Redwood City, California, is seeking a Senior Manager for Clinical Data Management. This role involves ensuring optimized data collection and access across EDC and non-EDC sources while maintaining compliance with CDISC standards.

The ideal candidate will have over 5 years of experience in the clinical trials industry, particularly in data management for oncology or rare diseases. Corcept values dedication and aims to provide novel treatments for serious medical needs.

Formación

• 5+ years' experience in data management in the clinical trial industry.
• Experience managing Data Management CROs and vendors.
• Experience with Oncology or rare disease clinical trials.

Responsabilidades

• Ensure optimized data collection and flow across EDC and non-EDC data sources.
• Manage data management service providers for quality deliverables.
• Review and assess data query resolution metrics.

Conocimientos

Relational database experience

SAS

Clinical data management systems

Hands-on experience with EDC systems

Familiarity with Data Visualization Tools

In-depth understanding of Data Management regulatory guidelines

Strong management abilities

Educación

Bachelor's or higher in science, math, or computer science

Herramientas

Tableau

Rave

Medrio

Descripción del empleo

Senior Manager, Clinical Data Management

Redwood City, California, United States

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.

Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.

Corcept is headquartered in Redwood City, California.

The Sr Manager, Clinical Data Management, ensures optimized data collection, flow, and access across EDC and non-EDC data sources. Responsible for accuracy, completeness, and CDISC compliance of Corcept clinical databases.

Responsibilities:

• Provides input into the design of data flow across EDC and non-EDC data sources across vendor network
• Manages data management service providers to ensure the quality of deliverables and that timelines are met
• Develops and contributes to the design of processes enabling near-real-time data access for Corcept clinical trials
• Ensure data quality of clinical database through the implementation of CDISC compliance
• Reviews and critically assesses data query resolution metrics and suggests process improvement
• Reviews study protocols to ensure that data collection and CRF design meet study objectives
• Manages and oversees SAE and external vendor reconciliation between clinical and applicable databases
• Review clinical data for completeness, accuracy, and consistency in accordance with the investigational plan
• Provide subject matter expertise to project team members during all phases of the project life cycle
• Provides accurate and timely clinical data to internal and external customers upon request
• Manage development, test, and maintain data management systems
• Support the development and periodic review of Data Management specific SOPs, WIs, and templates
• Provide subject matter expertise prior, during, and post internal and external audits and inspections
• Maintain compliance with company and study-specific learning requirements

Preferred Skills, Qualifications, or Technical Proficiencies:

• Relational database experience, SAS, and clinical data management systems
• Knowledge of CDISC/SDTM. Hands-on experience preferred
• Hands-on experience working with mainstream EDC systems (e.g. Rave, Medrio)
• Familiarity with Data Visualization Tools for quick customized data access (e.g. Tableau, RShiny) a plus
• In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11
• Demonstrated strong management abilities for project and staff management of Data Management Deliverables in clinical development

Preferred Education and Experience:

• Bachelor's or higher in science, math, or computer science
• 5+ years' experience in data management in the clinical trial industry (med device, pharma, or biotech)
• Experience in IT-related field
• Experience with Oncology or rare disease clinical trials and CDISC therapeutic area standards
• Experience with management of data flow and curation of biomarker data
• Experience managing Data Management CROs and vendors

The pay range that the Company reasonably expects to pay for this headquarters-based position is $170,550 $200,700; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

Corcept is an Equal Opportunity Employer

Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.