Clinical Data Manager Jobs

About The Position

Requirements

• Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or a related discipline, or equivalent relevant experience
• Minimum of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries
• Excellent attention to detail
• Excellent written and verbal communication skills
• Strong knowledge of data management best practices and technologies as applied to clinical trials
• Excellent communication and interpersonal skills to collaborate with cross-functional internal and external teams
• Strong understanding of clinical trial processes, protocol documents (protocols, Statistical Analysis Plans (SAPs), Case Report Forms (CRFs), study reports), and related procedures
• Strong analytical and problem-solving skills
• Independent and autonomous project oversight skills

Responsibilities

• Provide fully independent and autonomous leadership of data management services (start-up, conduct, and closeout) across multiple complex global projects/programs
• Ensure appropriate resources are allocated to complete all data management (DM) activities on time and within budget
• Prepare DM trial documentation, including Data Management Plans (DMPs), Database Specifications, Edit Check Specifications, CRF Completion Guidelines (CCGs), and Data Transfer Agreements (DTAs)
• Ensure effective User Acceptance Testing (UAT) is performed
• Write external vendor reconciliation specifications for programming reconciliation outputs (e.g., Serious Adverse Events, Interactive Response Technology (IRT), Central Laboratory)
• Oversee data cleaning activities
• Produce metrics to monitor progress of trial activities
• Ensure all database lock activities are completed on time
• Represent Worldwide Clinical Trials Data Management at both internal and external study meeting calls, including providing input
• Monitor project scope, budgets, and risks and alert DM Management of any concerns
• Liaise with DM Management at regular intervals to discuss progress and any outstanding issues (e.g., during Project Review Meetings)
• Collaborate with internal Worldwide Clinical Trials departments working on the same project
• Provide feedback on process improvements to DM Management and/or Subject Matter Experts (SMEs)
• Participate in and lead process reviews
• Provide training, support, and mentorship to other members of the DM department
• Participate, as necessary, in sponsor audits, regulatory authority inspections, and other third-party meetings
• Perform other duties as assigned.

Benefits

• competitive benefits package