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Clinical Data Management Director

Remote:

Full Remote

Contract:

Full time

Experience:

Expert & Leadership (>10 years)

Work from:

New York (USA), United States

Offer summary

Qualifications:

12 years of data management experience, B.S./B.A. with 8 years or master's degree with 6 years, 4 years in the Pharmaceutical/Biotechnology industry, 6 years of experience supervising teams, SQL or SAS programming skills desirable.

Key responsabilities:

Provide expertise in data management processes
Oversee eCRF/CRF specifications and database maintenance
Conduct data reviews and ensure issue resolution
Facilitate internal meetings and write SOPs
Manage team activities, timelines, and training

Executive Staff Recruiters / ESR Healthcare https://www.careermd.com/physicians/careerfairs/employersnapshot.aspx?pid=244502474

2 - 10 Employees

See more Executive Staff Recruiters / ESR Healthcare offers

Job description

Your missions

Description

This role involves providing comprehensive expertise and support in Clinical Data Management to internal project teams, clients, and Clinical Research Organizations (CROs). You will be instrumental in ensuring the proper handling and processing of clinical data, while managing a team effectively to achieve project goals.

Responsibilities

Provide data management expertise in:

Study startup documents
Data cleaning, DCF/query tracking
Database QC and maintenance of data management binders
SAE/AE reconciliation

Plan, perform, and oversee development of specifications for eCRFs/CRFs, edit checks, and electronic data handling.
Conduct cross-functional data reviews and track issue resolutions.
Participate in the innovation and implementation of new technologies to improve data management processes.
Ensure quality control procedures adhere to data management activities.
Write and update Standard Operating Procedures (SOPs) and training guidelines.
Facilitate internal team and client meetings.
Review study data quality and provide metrics.
Manage timelines, resources, and identify process inefficiencies.
Assist in proposals and budgets for new and ongoing projects.
Direct and manage daily activities of team members, including training and performance reviews.

Knowledge & Skill Requirements

12 years of data management experience, or B.S./B.A. in a science or technical discipline with 8 years of experience, or a master’s degree with 6 years of experience; at least 4 years in the Pharmaceutical/Biotechnology industry or CRO environment.
6 years of experience supervising Clinical Data Managers.
SQL or SAS programming skills are desirable.
Experience with various data collection and Electronic Data Capture (EDC) systems.
Excellent oral and written communication skills.
Ability to work collaboratively in a multi-disciplinary environment.
Strong knowledge of FDA, EMA, ICH guidelines, and Good Clinical Practices related to clinical development programs.

Employment Type: Full-Time