Manager -Clinical Data Management.

Manager Clinical Data Management

On behalf of my client, I am recruiting for a Manager of Clinical Data Management.

Job Responsibilities

• Works collaboratively with Programming (Clinical and Statistical) Clinical Operations,
• Biostatistics and others such as Clinical Research, Global Patient Safety, Regulatory and Project Management staff to meet project deliverables and timelines for moderately complex clinical data acquisition, quality checking and reporting.
• Ensures completeness, accuracy and consistency of clinical data and data structure across all Training and mentoring of CDM staff on business process and clinical programs.
• Participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM.
• Participate in CDM and cross functional initiative teams.
• Project level coordination of CDM tasks, while demonstrating knowledge of hands‐on work.
• Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
• Support of regulatory submission activities for assigned project.
• Assist with response to questions and findings from Clinical Quality Assurance (CQA) and other audits at the study / vendor level.
• Communicates with functional peers regarding project status and issues and ensure project team goals are met.
• Participates in the recruiting and hiring process for CDMAs and support their professional development.
• Provides guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Working knowledge and experience with FDA/EMA regulations and familiarity with web‐based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA.
• Anticipates internal resource needs and external costs for the short and long term. Works with senior management and HR to ensure long‐term resource allocation within a therapeutic area.
• Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner.

Qualifications/Experience:

• Bachelor’s degree or higher, in a relevant subject.
• Approx. 10 years of experience in a similar position with experience assisting with data management activities for regulatory submissions.
• Experience leading and providing oversight for the execution of data management activities at the project level.