Director Clinical Data Management

The Lotus Group LLC; United States; Remoto; USD 120.000 - 150.000; Tempo pieno

Descrizione del lavoro

A leading staffing agency is partnering with a biotech firm to hire a Director of Clinical Data Management. This remote senior leadership role involves overseeing the Data Management department, ensuring high standards in clinical trial data. Candidates should have over 10 years of experience in clinical data management and leadership, with expertise in CDISC standards and regulatory requirements.

Competenze

• 10+ years of experience in Clinical Data Management within pharma/biotech.
• At least 5 years in leadership roles.
• Proven track record of leading global teams.
• Experience with data for all phases of clinical trials.
• Expertise in regulatory submission requirements.

Mansioni

• Provide strategic and operational leadership for the Clinical Data Management department.
• Build, mentor, and manage a team of data management professionals.
• Establish and maintain data management standards and processes.
• Oversee vendor/CRO partnerships, ensuring alignment with timelines and budgets.

Conoscenze

Leadership

Communication

Cross-functional collaboration

CDISC standards

EDC systems

Formazione

Bachelor’s or Master’s degree in Life Sciences, Data Management, or related field

Descrizione del lavoro

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The Lotus Group is partnering with a leading biotech client to hire a Director of Clinical Data Management. This is a senior leadership role reporting into the Head of Biometrics and will function as the head of the department. The Director will be responsible for building and guiding the Data Management function, ensuring clinical trial data is delivered with the highest standards of quality, compliance, and efficiency.

Responsibilities

• Provide strategic and operational leadership for the Clinical Data Management department.
• Build, mentor, and manage a team of data management professionals to support clinical development programs.
• Establish and maintain data management standards, processes, and systems to ensure accuracy and compliance.
• Partner cross-functionally with Biostatistics, Clinical Operations, Programming, and Safety to enable seamless trial execution and regulatory submissions.
• Oversee vendor/CRO partnerships, ensuring alignment with timelines, budgets, and quality expectations.
• Contribute to biometrics leadership discussions and strategic planning to support company growth.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Data Management, or related field.
• 10+ years of experience in Clinical Data Management within pharma/biotech, with at least 5 years in leadership roles.
• Proven track record of leading global teams and managing data for all phases of clinical trials.
• Expertise in CDISC standards, EDC systems, and regulatory submission requirements.
• Strong leadership, communication, and cross-functional collaboration skills.

Why This Opportunity?

• Lead and shape the Clinical Data Management function at an innovative biotech.
• Play a visible role within the Biometrics leadership team.
• Drive strategy while remaining hands-on with a diverse portfolio of programs.
• Fully remote flexibility while operating in a senior leadership capacity.

Seniority level

• Director

Employment type

• Full-time

Job function

• Research and Project Management

Industries

• Pharmaceutical Manufacturing and Biotechnology Research

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