Senior Clinical Data Management Associate

🔥 19 hours ago

🇺🇸 United States – Remote

💵 $115.3k - $149.2k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 • Report to the Senior Manager, Clinical Data Management • Collaborate to meet 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 structures • 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 to ensure quality • Assist with vendor implementation of routine clinical data management processes, including data entry, data quality checking, data transfer, and reporting • Create or support Data Transfer Plans and other 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 compliance with regulatory bodies • Participate in the design and implementation of clinical data management processes • 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 • Ability to work flexibly with changing priorities, remain detail-oriented, work well under pressure, and 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 • Must be eligible to work in the United States as this is a United States-based role

🏖️ Benefits

• Discretionary annual bonus eligibility • Discretionary stock-based long-term incentives eligibility may vary based on role • Paid time off • Company-sponsored medical insurance • Company-sponsored dental insurance • Company-sponsored vision insurance • Company-sponsored life insurance • Inclusive work environment • Reasonable accommodation in the job application process