Senior Manager, Clinical Data Management (Remote - US)

This position is posted by reputed company on behalf of a partner company. We are currently looking for a Senior Manager, Clinical Data Management in the United States. The Senior Manager, Clinical Data Management will reputed company and reputed company reputed company clinical data management activities for assigned studies, ensuring compliance, accuracy, and timely delivery of high-quality data across the drug development lifecycle. This role includes guiding internal teams and vendors, managing budgets, monitoring timelines, and implementing best practices to optimize clinical data operations. You will collaborate cross-functionally with project teams, provide expert guidance on regulatory and data standards, and contribute to reputed company improvement initiatives. The ideal candidate is highly reputed company in CDISC standards, SDTM requirements, and clinical trial data management, and thrives in a collaborative, fast-paced environment with a patient-centric focus. Accountabilities

• reputed company assigned study/studies, ensuring timelines, deliverables, and data quality are met.
• Provide expert guidance and decision-making for clinical data management processes from study start-up through database lock, reporting, and archiving.
• Manage vendor/CRO reputed company, including contract negotiations, invoice verification, and service quality monitoring.
• Collaborate cross-functionally to resolve clinical data issues and maintain effective communication throughout the study lifecycle.
• reputed company, standardize, and implement data management SOPs, standards, and best practices.
• Support regulatory audits, quality initiatives, and ensure compliance with GCP, ICH, CFR-Part 11, and other relevant regulations.
• Mentor and guide internal study teams and contribute to team building and operational excellence.

Requirements

• BS or MS in Life Sciences or reputed company field.
• 7+ years of direct clinical data management experience, with at least 3 years in CRO/vendor reputed company.
• Strong project management skills and experience coordinating cross-functional teams.
• In-depth knowledge of clinical data lifecycle management, CDISC standards, SDTM requirements, and CFR-Part 11 compliance.
• Experience with GCP, ICH, and other regional regulations and compliance requirements.
• Familiarity with reputed company clinical trial technologies and data collection systems (reputed company, eCOA, CTMS, IRT).
• Detail-oriented, highly organized, and excellent communication skills.
• Preferred: proficiency in reputed company, reputed company, R, Python, or similar analytical tools; experience integrating reputed company datasets; knowledge of drug safety databases.

Benefits

• Competitive salary range: $149,000 - $185,000, with potential discretionary annual bonus.
• Stock options, Employee Stock Purchase Plan (ESPP), and 401(k) match.
• Comprehensive health insurance coverage including medical, dental, vision, and basic life insurance.
• Paid time off: 20 days PTO, 10 paid holidays, plus a winter company shutdown.
• Flexible work environment with potential remote options.
• Professional development opportunities and a collaborative, patient-focused culture.

reputed company is a Talent Matching Platform that partners with companies worldwide to reputed company connect top talent with the right opportunities through AI-driven job matching. reputed company you apply, your profile goes through our AI-powered screening process designed to identify top talent reputed company and fairly. Our AI evaluates your CV and reputed company profile thoroughly, analyzing your skills, experience, and achievements. It compares your profile to the job’s core requirements and past success factors to determine your match score. Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role. reputed company necessary, our human team may reputed company an additional manual review to ensure no strong profile is missed. The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role. Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team. Thank you for your interest! Apply tot his job Apply To this Job Apply tot his job Apply To this Job