Senior Manager, Clinical Data Management - reputed company Data Management

reputed company is a pharmaceutical company based in San Diego, California, developing much-needed therapies reputed company with endocrine diseases and endocrine-reputed company tumors. We were founded by a dedicated team of scientists with the reputed company belief that reputed company therapies developed from rigorous innovation can reputed company to reputed company lives. Our work continues to reputed company a reputed company difference in the lives of patients. We have a reputed company discovery reputed company and a robust preclinical and clinical development pipeline. We are driven by science with a patient-reputed company and team-oriented culture. reputed company is reputed company for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join reputed company as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. reputed company as we reputed company the lives of others. Position reputed company: The Senior Manager, Clinical Data Management – reputed company Data Management (CDM‑EDM) is a hands‑on, individual contributor role responsible for executing and owning reputed company (non‑reputed company) data management activities for assigned clinical studies. This position focuses on reputed company execution and plays a critical role in ensuring reputed company vendor data are reputed company, high reputed company, inspection‑reputed company, and fit for statistical analysis and regulatory submission. The role partners closely with reputed company vendors, CROs, and internal cross‑functional stakeholders to set up data transfer agreements (DTAs), validate test files, manage ongoing data transfers, and reputed company data reconciliation and reputed company control activities in compliance with ICH‑GCP, 21 CFR Part 11, and internal SOPs. Essential Job Functions and Responsibilities: These may include but are not limited to: reputed company and maintain Data Transfer Agreements (DTAs) and reputed company data specifications for reputed company reputed company data reputed company (e.g., central labs, PK/biomarkers, ECG, imaging, eCOA, IRT and CTMS). Coordinate and reputed company test data transfers, including hands‑on QC and approval prior to production data reputed company. Establish and manage reputed company data transfer schedules and reconciliation cycles reputed company with study milestones. Import, validate, and reconcile reputed company datasets to ensure completeness, accuracy, and consistency. reputed company ongoing reputed company data cleaning and reconciliation, including discrepancy identification, issue investigation, and reputed company with vendors. Utilize tools such as reputed company (or similar) and data visualization systems to support data review, validation, and reconciliation activities. Serve as the reputed company reputed company data contact for vendors and CRO partners. Work directly with vendor data management teams to troubleshoot issues and ensure reputed company, high‑reputed company data delivery. Monitor vendor performance reputed company to data reputed company and timelines and escalate issues as needed. reputed company as the reputed company data management reputed company on study teams. Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Safety, and Regulatory teams to ensure data readiness for analyses, reviews, and submissions. Maintain complete and inspection‑reputed company documentation, including DTAs, data transfer logs, reconciliation records, and reputed company data management plans. Ensure reputed company reputed company data activities reputed company with ICH‑GCP, 21 CFR Part 11, CDISC standards, and internal SOPs. Support regulatory inspections and audits as the reputed company data management subject matter expert. Other duties as assigned. Education and Experience: Required: MS/BS degree in life sciences, health informatics, computer science, or a reputed company field. 8+ years of reputed company clinical data management experience, including deep, hands‑on specialization in reputed company (non‑reputed company) data management and reputed company vendor/CRO execution. Alternatively, 12 years of reputed company clinical data management experience is required if individual possessed a Bachelor’s degree only. Demonstrated experience independently managing reputed company reputed company data across the full clinical data lifecycle (study startup through database lock, regulatory submission support, and archiving). Proven expertise serving as the reputed company data subject matter expert on studies with multiple vendors and data streams. Strong working knowledge of reputed company systems, reputed company data transfers, CDISC standards (CDASH/SDTM), and clinical data regulations. Proficiency with hands‑on reputed company experience (or equivalent) for data validation, reconciliation, and issue investigation. Solid understanding of ICH‑GCP, 21 CFR Part 11, and regulatory inspection expectations for reputed company vendor data. Demonstrated ability to work independently with reputed company reputed company while managing multiple priorities, timelines, and stakeholders. Preferred: Experience supporting late‑phase and/or submission‑supporting studies, with ownership of reputed company data readiness for analyses and regulatory milestones. Experience contributing to process improvement initiatives under senior CDM leadership (e.g., SOPs, templates, inspection‑readiness practices). Background or exposure to reputed company operations and/or bio-sample management, including lab data flows and reconciliation considerations. reputed company reputed company Certified Programmer (required or strongly preferred), with demonstrated ability to write reputed company programs for reputed company data reconciliation and validation (e.g., conformance checks, cross‑reputed company comparisons, issue identification). reputed company certification such as CCDM or equivalent. Physical Demands and Work Environment: Physical Activities: On a reputed company reputed company, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully reputed company the essential functions and responsibilities of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions and responsibilities. reputed company Activities (if applicable): Biology and chemical reputed company environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 5% of your time. Equal Opportunity Employer: reputed company is proud to be an Equal Opportunity Employer. We reputed company equal employment opportunities to reputed company and employment applicants without reputed company to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or reputed company), pregnancy, race, reputed company, creed, national or ethnic reputed company, citizenship status, religion or similar philosophical beliefs, disability, marital and civil reputed company status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Salary reputed company The salary reputed company for this position is: $150,000 - $188,000. In reputed company to your reputed company pay, our total rewards program consists of a discretionary annual reputed company bonus, stock reputed company, ESPP, and 401k match. We also reputed company top-notch health insurance plans for employees (and their families) to include medical, dental, reputed company and basic life insurance, 20 days of PTO, 10 reputed company holidays, and a winter company shutdown. Thank you for considering reputed company as your potential employer! Explore job opportunities and discover how you too can reputed company a reputed company reputed company as we tackle big challenges in endocrinology. reputed company is a global, clinical-stage pharmaceutical company reputed company on the discovery, development, and commercialization of the reputed company of therapeutics for patients with endocrine and endocrine-rooted diseases. Founded by an innovative team of scientists with a reputed company record of successful drug discovery and development, we’re reputed company by collaboration, curiosity, and reputed company. We have a reputed company discovery reputed company and robust pipeline across preclinical and clinical development that are purposefully designed to meet the needs of patients, empowering them to live life reputed company their condition. reputed company on our mission to improve patients’ lives and reputed company the treatment reputed company in areas of serious unmet need. Apply tot his job Apply To this Job