Senior Clinical Data Management Associate

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $115.3k - $149.2k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1987

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Gilead Sciences is a leading biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapeutics for patients with life-threatening diseases. The company is highly recognized for its contributions in virology, particularly HIV and hepatitis, and is actively expanding its therapeutic reach into fields like oncology and inflammation. Gilead has a strong pipeline of medicines, with over 25 products available globally and 50 clinical programs. Known for its commitment to health equity, the company also actively funds HIV research and causes. Gilead's dedication to scientific innovation and health equity aims to tackle the world's most pressing health challenges, improving patient lives globally.

📋 Description

• Oversee all aspects of clinical data management studies from start-up to close-out for Kite’s clinical development programs • Work closely with Biostatistics, Programming, Clinical Operations, Safety, and Regulatory teams • Collaborate on project deliverables and timelines for clinical data collection, quality checking, and reporting • Handle multiple studies complex in scope and volume • Lead studies and projects without supervision oversight • Ensure completeness, accuracy, and consistency of clinical data and data structure • Lead preparation and design of eCRFs • Review study protocols and lead or assist in planning and implementing data management portions of clinical studies • Interact with site coordinators, investigators, and field clinical staff to collect data and resolve queries • Use reports to track study progress and ensure timeliness and quality expectations • Prepare and manage data management timelines • Provide CDM expertise for external vendor data coordination, collection, and cleaning • Manage CDM deliverables with internal and external cross-functional teams • Review clinical data on an ongoing basis • Support vendor processes including data entry, data quality checking, data transfer, and reporting • Create or support Data Transfer Plans and external data documentation • Manage and coordinate external data deliverables • Coordinate query management, report delivery, study timelines, and database snapshots for analysis including Safety Review • Ensure adherence to standard business processes within CDM systems and regulatory compliance • Participate in clinical data management process design and implementation • Serve as a point of contact for the study management team • Facilitate meetings and presentations • Delegate tasks to applicable staff members • Identify, communicate, and escalate project-level issues involving processes, timelines, resourcing, and performance

🎯 Requirements

• High School diploma and 9+ years of experience in Data Management, OR BS/BA in life science or related discipline and 5+ years of experience in Data Management, OR MS/MA in life sciences or related discipline and 3+ years of experience in Data Management, OR PhD in life sciences or related discipline and 2+ years of experience in Data Management • CDM oncology experience and knowledge of hematological cancers / cell therapy • Scientific background and experience with lab data handling • Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management • Experience managing clinical data management deliverables for regulatory submission • Ability to problem solve • Exceptional people/project leadership skills • Familiarity with industry-wide thesauri/dictionaries such as MedDRA and WHODD • Proficiency in web-based Electronic Data Capture, such as Medidata Rave and other clinical data management systems • Excellent verbal and written communication and interpersonal skills • Ability to clearly describe critical technical CDM aspects to non-CDM staff • Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks • Demonstrated meeting facilitation/presentation skills • Demonstrated ability to appropriately delegate tasks to applicable staff members • Demonstrated ability to identify, communicate, and escalate project-level issues

🏖️ Benefits

• Discretionary annual bonus eligibility • Discretionary stock-based long-term incentives eligibility • Paid time off • Company-sponsored medical insurance • Company-sponsored dental insurance • Company-sponsored vision insurance • Company-sponsored life insurance