Manager, Clinical Data Management in a CRO - Full Time REMOTE, some travel

Elan Solutions; California (MO); Remote; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Manager for Clinical Data Management to lead a talented team in delivering data management expertise to project teams and clients. This full-time role encompasses overseeing data quality, managing timelines, and innovating processes to improve efficiency. The ideal candidate will possess extensive experience in data management, strong communication skills, and a solid understanding of FDA and ICH guidelines. Join a collaborative environment where your contributions will drive impactful results in the pharmaceutical and biotechnology sectors. If you are passionate about data management and leadership, this opportunity is perfect for you!

Qualifications

• 12+ years of hands-on data management experience required.
• 6-7 years of managerial experience managing a team of at least 5.

Responsibilities

• Provide data management expertise to project teams and clients.
• Oversee development of specifications for eCRFs and data handling.
• Manage timelines and resources to meet project deadlines.

Skills

Data Management

Communication Skills

Team Management

Problem Solving

Knowledge of FDA/EMA/ICH Guidelines

Education

B.S./B.A. in Science or Technical Discipline

M.S. Degree

Tools

SQL

SAS

EDC Systems

Job description

Job Description / Summary

The Manager, Clinical Data Management is a full-time exempt position reporting to the Director, Clinical Data Management.

PLEASE NOTE: Candidates must have a valid Green Card or U.S. citizenship. No visa sponsorship is available now or in the future.

Must Have

• 12+ years of hands-on data management experience.
• 6-7 years of managerial experience, managing a team of at least 5 people.
• 4+ years of experience in the CRO environment.
• Excellent oral and written communication skills.
• Ability to work in the PST time zone (flexible).
• Willingness to travel 2-3 times a year when necessary.

Responsibilities

• Provide data management expertise to project teams, clients, and CROs, including study startup documents, data cleaning, DCF/query tracking, database QC, and SAE/AE reconciliation.
• Oversee development of specifications for eCRFs/CRF, edit checks, electronic data handling, manual review, and User Acceptance Testing.
• Conduct cross-functional data reviews, identify issues, and track resolutions.
• Innovate and implement new technologies for process improvements.
• Ensure adherence to quality control procedures.
• Write and update SOPs/training guidelines.
• Facilitate internal study team, client, and CRO meetings.
• Review study data quality, provide metrics, and report out-of-scope activities.
• Manage timelines and resources to meet deadlines.
• Identify and recommend solutions for process inefficiencies.
• Assist in preparing proposals and budgets for new and ongoing projects.
• Direct and manage team members, including training, resource assignment, and performance reviews.

Education and Experience Requirements

• 12 years of hands-on data management experience.
• 6-7 years of managerial experience, managing a team of 5+ people.
• B.S./B.A. in a science or technical discipline with 8 years of data management experience, or MS degree with 6 years of data management experience; minimum 4 years in the Pharmaceutical/Biotechnology industry or CRO environment.
• Proficiency in SQL or SAS is desirable but not required.
• Experience with various data collection and EDC systems.

Knowledge & Skills Requirements

• Excellent oral and written communication skills.
• Ability to work collaboratively in a multi-disciplinary environment.
• Good knowledge of FDA, EMA, ICH guidelines, and GCPs, especially related to data handling and processing.

Salary and Benefits

• Market rate compensation as base salary with all the benefits.