What the Senior Clinical Data Manager does at Worldwide

Oversee, lead, manage, and provide technical expertise within assigned projects to ensure they are executed in an efficient, accurate, and timely manner to the Sponsor’s satisfaction.

What you will do

• 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. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

What you bring to the role

• 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

Your experience

• 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
• Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.