Note: The job is a remote job and is open to candidates in USA. Worldwide Clinical Trials is a global, midsize CRO focused on innovative approaches to improve patient lives. The Senior Clinical Data Manager will oversee and manage data management services across multiple global projects, ensuring efficiency and accuracy in the execution of these projects.
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. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
Skills
- 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
- 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
Company Overview
Company H1B Sponsorship