Senior Clinical Data Manager

Role Overview

• Oversee, lead, manage, and provide technical expertise within the assigned projects to ensure that they are executed in an efficient, accurate, and timely manner to the Sponsor’s satisfaction.
• Provide fully independent and autonomous leadership of data management services (start up, conduct, and close out) across multiple complex global projects/programs.
• Ensure appropriate resources are allocated to complete all DM activities on time and within budget.
• Prepare DM trial documentation (DMP, DB Specifications, Edit check specifications, CCGs, DTAs).
• Ensure effective UAT is performed.
• Write external vendor reconciliation specifications for programming reconciliation outputs (e.g., Serious Adverse Events, IRT, Central Laboratory).
• Oversee data cleaning activities.
• Produce metrics to monitor the progress of trial activities.
• Ensure all database lock activities are completed on time.
• Represent WorldWide DM 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 issues outstanding (e.g., during Project Review Meetings).
• Collaborate with internal Worldwide departments working on the same project.
• Provide feedback on process improvements to DM Management and/or 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.

Requirements

• Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or related discipline — or equivalent relevant experience.
• Min of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.
• Strong knowledge of data management best practices & 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 process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Strong analytical and problem-solving skills.
• Independent and autonomous project oversight skills.

Benefits

• Diverse and inclusive environment
• Professional development opportunities