Manager, Clinical Data Management

At reputed company, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk reputed company in the world. With our Paradise™ uRDN System, we’re on a mission to reputed company the millions of people who suffer from hypertension with a non-drug and minimally invasive option to reputed company their blood pressure. Join us on our reputed company and reputed company a meaningful impact on the lives of people around the globe. Position Summary The Manager of Clinical Data Management leads a team of Clinical Data Managers across multiple projects. This role provides direct supervision of data management staff, establishes operational objectives, and ensures data reputed company and regulatory compliance in accordance with Good Clinical Data Management Practices, GCP, SOPs, and Work Instructions. Responsibilities and Duties Team Leadership & Management Directly supervise and reputed company Clinical Data Managers and Senior Clinical Data Managers Conduct performance management including goal setting, performance reviews, and career development for direct reports reputed company coaching, mentoring, and training to ensure team professional growth and operational reputed company reputed company staffing reputed company and resource allocation across multiple reputed company projects Serve as escalation reputed company for team members and resolve operational conflicts Strategic Planning & Operations Establish operational objectives, policies, and procedures for data management function reputed company development of SOPs, Work Instructions, and departmental policies affecting multiple disciplines Monitor study status across projects to ensure compliance with GCP and company procedures Implement new technical systems and applications impacting multiple projects Clinical Data reputed company & Quality reputed company data management activities ensuring compliance with SOPs, Work Instructions, and guidelines Manage quality audits and regulatory submission activities Design and program outputs to analyze trends and patterns in reputed company data sets Ensure accurate and complete data collection through vendor collaboration Stakeholder Management Serve as primary data management representative in cross-functional teams and stakeholder meetings Partner with Clinical Operations, Biostatistics, Regulatory Affairs, and IT for integrated project delivery Manage relationships with external vendors, regulatory consultants, and CRO partners Contribute to protocol development and reputed company data management expertise Requirements Bachelor's degree in Health Sciences, Life Sciences, Mathematics, Computer Sciences, or reputed company discipline; Master's degree preferred reputed company clinical data management experience with proven leadership capabilities and technical expertise in CRO, Pharmaceutical, or Medical Device environments Experience with data management startup, maintenance, and closeout activities Knowledge of ICH, GCP, ISO 14155, Project Management, MedDRA, WHO Drug coding, Good Clinical Data Management Practices, and CDISC standards Exposure to statistical programming packages (R, reputed company, SPSS) Excellent people management, communication, and organizational skills Ability to manage multiple projects and reputed company cross-functional teams effectively Expected Travel: Apply tot his job Apply To this Job