Sr. Manager, Clinical Data Management

Sr. Manager, Clinical Data Management Senior Manager, CDM oversees clinical data management activities across multiple studies from study start‑up through study closure. This includes prioritizing projects, developing and enhancing data management processes to ensure complete, accurate, high‑quality clinical data and adherence to Good Clinical Practices and FDA regulations. Responsibilities Develop and implement SOPs to ensure GCP/ICH compliance for data management, database operations, clinical report writing, case report forms, and associated procedures. Participate on corporate global clinical research teams ensuring that colleagues are updated on all relevant issues. Assist in budget planning and resource allocation related to data management. Develop and implement clinical trial database, including CRF development and all aspects of data management. Manage, plan, and coordinate the activities of the data management team members. Oversee data management vendors, ensuring requirements are met and consistent. Audit data management vendors, as appropriate. Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and other applicable regulations and guidelines. Review and approve CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans. Review study documents, e.g., clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells. Participate in the development of EDC UAT and custom report specifications as needed. Plan, manage and coordinate all data management activities to ensure consistency of the clinical data process across studies. Work collaboratively with biostatistics, programming and other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. Contribute to activities supporting audits & inspection readiness and regulatory inspections. Perform additional responsibilities as assigned. Salary Range : $140,500 – $184,500. Financial compensation packages may be higher or lower than what is listed and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. Qualifications Bachelor's degree in Science, Computer Science, or equivalent combination of training and experience. Minimum seven (7) years of clinical data‑management experience in the pharmaceutical, device or CRO setting. Previous supervisory experience. Proven ability to prioritize and manage multiple tasks with conflicting deadlines in support of corporate goals and objectives. Experience reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans, Data Transfer Plans. Desired Qualifications Well organized, analytical and self‑confident person. Solid experience in developing, implementing, and validating data management systems and Electronic Data Capture (EDC). Strong communication skills and interpersonal skills, ability to coach and mentor. Knowledgeable in GCP standards, FDA and ICH guidelines, and recommended CDM best practices. Hands‑on extensive knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission. Able to work independently, as well as part of a team. Equal Employment Opportunity We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law. Fair Chance Ordinance If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance. #J-18808-Ljbffr 6AM City, LLC