• , US

Company:  Confidential

Job Title: VP, Clinical Data Management & Standards

Job Number: 77866

Location: , US

Job Description

Looking for a Director/Senior Director in Clinical Pharmacology, responsibilities include overseeing trials, collaborating with teams, managing programs, and reporting to the SVP, Pharmaceutical Sciences. Expertise in pharmacology/pharmacometrics with a PhD or PharmD and 7-10 years of industry experience preferred.

Responsibilities

* Lead Data Management team. * Provide expertise on data standards, quality, and validation. * Oversee clinical study data management for outsourced trials. * Author/review eCRFs, CCGs, and Data Management Plans. * Develop global data standards library. * Automate data delivery processes. * Utilize reporting functions from software. * Drive data delivery specifications and training. * Support data integration with visualization tools. * Handle additional duties as needed.

Required Skills

* Bachelor’s Degree in computer science or a related field; or Bachelor’s Degree with significant clinical data management experience in biotech/pharma. * Over 10 years of management experience in clinical research, preferably in oncology and with EDC platforms. * Strong vendor management and oversight skills. * Technical proficiency in data platforms; programming experience is a plus. * Designing clinical trials. * Cross-functional collaboration with Biostatistics, Statistical Programming, and Pharmacovigilance. * Familiarity with FDA and ICH GCP guidelines. * Experience with clinical data visualization tools. * Regulatory inspection and audit experience.

Application Deadline: 2024-06-03

 

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