Associate Director/Director, Clinical Data Management

Celcuity·
Remote
2w ago
Full-timeSeniorClinical Data ManagementOncologyUnknownMastersMay Not Sponsor
$200K - $230K/yr

Description

The Associate Director/Director, Clinical Data Management will focus on the CDM process from project planning through database lock. Responsibilities include managing timelines, ensuring quality of deliverables, participating in CRO selection, and overseeing junior staff. The candidate will manage or establish timelines, generate and review study documents, and monitor CDM activities. They will ensure the accuracy of clinical data and perform duties as assigned by management. The ideal candidate will have extensive experience in data management within the pharmaceutical industry, strong organizational skills, and the ability to work well with cross-functional teams.

Requirements

Bachelor’s or Master’s degree in Life Sciences, Computer Sciences, Mathematics, or related field required. Minimum of 10 years of DM experience in the pharmaceutical or biotechnology industry, with at least 3 years in staff management. In-depth knowledge of CDM principles and experience with EDC systems, preferably Medidata Rave. Prior oncology/hematology experience is highly desirable. Strong organizational and decision-making skills required, as well as familiarity with ICH, FDA, and GCP regulations.
Celcuity

Celcuity

DIAGNOSTICS

PI3K/mTOR therapies, Companion Diagnostics

LocationMN - Minneapolis
Open Jobs20
Oncology
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