Clinical Data manager remote prashanth at Esr healthcare New York, NY

Title

Clinical Data Manager - ESR Healthcare

Location

REMOTE (New York, NY)

Contract

6 months with possible renewal (Full‑Time)

Experience

12+ Years

Responsibilities

• Provide data management expertise and support to internal project teams, clients, and Clinical Research Organizations (CROs) including study startup documents, data cleaning, DCF/query tracking, database QC, compilation, and maintenance of data management binders and/or files, and SAE/AE reconciliation.
• Plan, perform, and oversee development of specifications for eCRFs/CRFs, edit checks, electronic data handling, manual review and execution of User Acceptance Testing.
• Conduct and orchestrate scheduled cross‑functional data reviews, identify issues and track through resolution.
• Participate in innovation and implementation of new technologies resulting in data management process improvements.
• Ensure adherence to quality control procedures for data management activities.
• Write and update Standard Operating Procedures (SOPs) and training guidelines for data management activities.
• Facilitate and oversee internal study team, client, and CRO meetings.
• Actively review and provide feedback on study data quality, including providing data management metrics, reviewing project statements of work, and reporting out‑of‑scope activities to the Director.
• Manage and monitor timelines, ensuring resources are available to meet them.
• Identify inconsistencies and inefficiencies in data management processes and recommend solutions.
• Assist in preparation of proposals and budgets for new projects and manage budgets for ongoing projects.
• Direct and manage team members in daily activities, including training, resource assignment, adherence to timelines, and conducting annual performance reviews.

Qualifications

• 12 years of data management experience, or a B.S./B.A. in a science or technical discipline with 8 years of data management experience, or an MS degree with 6 years of data management experience; minimum 4 years in the Pharmaceutical/Biotechnology industry or CRO environment, and a high degree of proficiency and autonomy in managerial responsibilities.
• Minimum 4+ years of direct line management experience, managing 3–4 direct reports.
• 6 years of experience supervising Clinical Data Managers and/or related team activities.
• Ability to program in SQL or SAS (desirable but not required).
• Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes.
• Excellent oral and written communication skills.
• Ability to work in a collaborative and multi‑disciplinary environment.
• Good knowledge of FDA, EMA, ICH guidelines, and Good Clinical Practice (GCP) regulation concerning data handling and processing.

Additional Details

Employment Type: Full‑Time.