SR. CLINICAL DATA MANAGER (REMOTE) (CONTRACT)

Remote contract position based in California.

About the role

The qualified candidate will manage all phases of clinical data management activities and support internal project teams, clients, and Clinical Research Organizations (CROs).

Responsibilities

• Review and approve study startup documents, Data Management Plan (DMP), Reconciliation Plan, Quality Control Plan, Coding Plan, Validation Plan, Communication Plan, and other required documentation.
• Supervise data cleaning activities, including processing Data Clarification Forms (DCF)/query tracking, conducting cross-functional data review/reconciliation, identifying issues, and tracking resolution.
• Design and/or approve final Electronic Case Report Form (eCRF)/Case Report Form (CRF), edit check specifications, case report form guidelines, and electronic data handling conventions.
• Manage database build activities, database validation, and review and execution of User Acceptance Testing of clinical databases.
• Facilitate internal study team, client, and CRO meetings.
• Actively review and provide feedback on study data quality, including data management metrics, and review project statements of work to identify and report out-of-scope activities.
• Assist manager in monitoring timelines and managing resources to meet deadlines.
• Identify inconsistencies and inefficiencies in data management processes and recommend solutions.
• Direct team members in daily activities, including training and supervising Clinical Data Managers I and II.

Requirements

• 9 years of data management experience, or a B.S./B.A. in a science or technical discipline with 6 years of data management experience, or an MS degree with 4 years of data management experience.
• Minimum of 4 years in the Pharmaceutical/Biotechnology industry or CRO environment.
• Meet the requirements of a Clinical Data Manager II with a high degree of proficiency and autonomy.
• 3 years’ experience supervising Clinical Data Managers and team activities.
• Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes.
• Good knowledge of FDA, EMA, ICH guidelines, and Good Clinical Practices (GCPs), including regulatory requirements for clinical development programs, especially related to data handling and processing.

Skills

• Ability to program in SQL or SAS (desirable but not required).
• Excellent oral and written communication skills.
• Ability to work in a collaborative and multi-disciplinary environment.
• Attention to detail, with the ability to prioritize and manage multiple projects with competing and aggressive timelines.

Pay

$70–78/hour based on experience level.