Senior Clinical Data Manager

Siemens Healthineers

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. We are currently looking for an ambitious Senior Clinical Data Manager to join our Clinical Operations business within Endovascular Robotics. As a Senior Clinical Data Manager you will be responsible for: Leading all Clinical Data Management activities for Endovascular Robotics, including oversight of the collection, validation, and processing of clinical trial data with high quality standards and in compliance with applicable regulations Working collaboratively with other Data Managers, Data Analysts, Clinical Operations Team Members, Programmers, Biostatisticians, Clinical Scientists/Researchers, Medical Directors, Chief Medical Officer, and Regulatory Team Members, both internal and external, to meet project deliverables and timelines for clinical data acquisition, quality assurance, analysis, and reporting Leading the development, review and implementation of processes, policies, SOPs, and associated documents for Clinical Data Management Designing and implementing Clinical Data Management Plans and other Data Management documents required for clinical studies (ex. Case Report Forms [CRFs], Data Review Plan, Clinical Data Coding Plan, CRF Completion Guidelines, etc.) Collaborating with Siemens Healthineers Advanced Therapies for implementation of controlled collection and usage of pre-, intra- and post-operative imaging and associated data Leading initial database and imaging repository builds, and implementing amendments as needed, in collaboration with internal and external support Study-level coordination and hands-on Clinical Data Management tasks, including clinical data review, data cleaning, discrepancy management, query resolution, and final reconciliation Supporting the Clinical Operations team with data-driven solutions (ex. site compliance metrics; Trial Master File tracking; study log compilation and analysis; preparation for interim/final analyses) Oversight of external Data Management and data vendors Ensuring completeness, correctness and consistency of clinical data and data structure across projects Communication, escalation, and problem-solving of study-level issues including processes, timelines, resourcing, performance, etc. Ensuring accurate tracking and reporting of study metrics and timelines Providing support for regulatory submission activities for assigned projects Providing guidance and training to internal team members, CROs, vendors, investigators, and study coordinators on study requirements as applicable

Requirements

Bachelor’s degree in a Biomedical or Data Science field or equivalent experience required
Minimum 8 years of relevant experience along with clinical background/experience in Clinical Data Management in a CRO or device/pharmaceutical Sponsor setting
Strong working knowledge of clinical trial processes, data management principles (ex. data custody, chain of control) and regulatory requirements for Clinical Data Management
Familiarity with web-based Electronic Data Capture (EDC), Interactive Response Technology (IRT), Clinical Data Management systems/processes (ex. Imaging repositories, Adjudication modules), and industry-wide coding dictionaries such as MedDRA
Excellent verbal and written communication skills, interpersonal skills, and analytical skills
Strong attention to detail
Strong organizational skills and time management capabilities
Ability to collaborate effectively with the study team, cross-functional team members, and external partners
Strong computer skills including knowledge of Microsoft Office Suite
An interest in working with our latest technology and willingness to learn about new advances in vascular robotics
Ability to travel up to 10%

Nice To Haves

Clinical Data Management certification (ex. CCDM) preferred

Responsibilities

Leading all Clinical Data Management activities for Endovascular Robotics, including oversight of the collection, validation, and processing of clinical trial data with high quality standards and in compliance with applicable regulations
Working collaboratively with other Data Managers, Data Analysts, Clinical Operations Team Members, Programmers, Biostatisticians, Clinical Scientists/Researchers, Medical Directors, Chief Medical Officer, and Regulatory Team Members, both internal and external, to meet project deliverables and timelines for clinical data acquisition, quality assurance, analysis, and reporting
Leading the development, review and implementation of processes, policies, SOPs, and associated documents for Clinical Data Management
Designing and implementing Clinical Data Management Plans and other Data Management documents required for clinical studies (ex. Case Report Forms [CRFs], Data Review Plan, Clinical Data Coding Plan, CRF Completion Guidelines, etc.)
Collaborating with Siemens Healthineers Advanced Therapies for implementation of controlled collection and usage of pre-, intra- and post-operative imaging and associated data
Leading initial database and imaging repository builds, and implementing amendments as needed, in collaboration with internal and external support
Study-level coordination and hands-on Clinical Data Management tasks, including clinical data review, data cleaning, discrepancy management, query resolution, and final reconciliation
Supporting the Clinical Operations team with data-driven solutions (ex. site compliance metrics; Trial Master File tracking; study log compilation and analysis; preparation for interim/final analyses)
Oversight of external Data Management and data vendors
Ensuring completeness, correctness and consistency of clinical data and data structure across projects
Communication, escalation, and problem-solving of study-level issues including processes, timelines, resourcing, performance, etc.
Ensuring accurate tracking and reporting of study metrics and timelines
Providing support for regulatory submission activities for assigned projects
Providing guidance and training to internal team members, CROs, vendors, investigators, and study coordinators on study requirements as applicable