Company: Confidential
Job Title: Senior Clinical Data Manager – 12 Month Contract
Job Number: 84571
Location: Hayward, US
Job Description
The Senior Clinical Data Manager (12-month contract) offers expertise in clinical data management to project teams, whether working with external vendors or in-house. The role requires a strong understanding of the clinical research lifecycle, data management processes, and relevant global regulations (e.g., ICH, GCP). Key responsibilities include managing data management tasks for projects and overseeing vendor performance for outsourced work. The position may also involve mentoring team members, directing external vendors, and participating in departmental initiatives and other projects.
Responsibilities
* Oversee data management tasks for assigned projects, including both outsourced and in-house models. * May act as the Lead Data Manager for in-house studies or oversee data management for outsourced projects. * Serve as a data management expert on cross-functional teams, providing updates, managing communications, and assessing and mitigating risks. * Manage start-up activities such as protocol development, EDC database documentation, and collaboration on data management plans. * Ensure data in clinical and vendor databases is suitable for analysis, including managing data transfer agreements. * Participate in data cleaning, reconciliation, query management, and reporting. * Contribute to study documents and maintain data management documentation for regulatory readiness. * Collaborate with stakeholders on data transfers and analytics. * Assist in developing and updating SOPs and related documentation.
Required Skills
* Bachelor’s degree or equivalent experience with at least 4 years in Clinical Data Management in relevant settings. * Strong communication skills, capable of explaining data management and EDC concepts to various teams. * Well-organized, detail-oriented, and self-motivated, with the ability to manage tasks in a fast-paced environment. * Experience handling multiple data management tasks across different clinical studies. * Proficient with EDC systems; familiarity with Medidata tools preferred. * Knowledge of data collection and cleaning best practices. * Experience managing vendors and data transfer processes. * Understanding of relevant regulations and industry data standards. * No travel required.We are an Equal Opportunity Employer and prohibit discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and do not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other legally protected status. EOE/AA/Vets
Application Deadline: 2024-11-04
To apply for this job please visit jobrxiv.org.