Senior Manager, Clinical Data Management

🔥 22 minutes ago

🇺🇸 United States – Remote

💵 $143.2k - $185.3k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Lead and oversee all aspects of clinical data management for Kite-sponsored Non-Interventional Studies, including Post-Marketing Required studies and Expanded Access Programs • Provide support and expertise for non-Kite-sponsored collaborative and Investigator Sponsored Research • Contribute to Kite Clinical Data Management strategy and processes • Build working relationships with Clinical Operations, Medical Affairs, and Translational Medicine • Provide study oversight during initiation and conduct, including protocol design and operating model expectations • Define expectations, set data management timelines, and oversee study status and activities with CRO counterparts • Collaborate with Clinical and Statistical Programming, Clinical Operations, Medical Affairs, Translational Medicine, Biostatistics, and other study team members • Review and manage the eTMF for completeness, accuracy, and inspection readiness • Oversee study documentation and adherence to regulatory expectations for data integrity and patient safety • Serve as primary contact for internal and external study team members • Oversee completeness, accuracy, and consistency of clinical data and data structures • Manage or provide oversight and guidance for Clinical Data Management deliverables • Lead Clinical Data Management representation during internal and Health Authority audits • Lead development, review, and implementation of Clinical Data Management processes, policies, SOPs, and related documents • Lead or participate in cross-functional Clinical Data Management initiatives • Provide input into organizational strategy and implement departmental change • Lead continuous improvement activities and implementation support • Prioritize and delegate study and initiative responsibilities • Assume expanded responsibility for complex clinical projects and direct reports • Communicate and escalate project-level issues involving processes, timelines, resourcing, and performance • Train and mentor Clinical Data Management roles • Create inclusion, develop talent, and empower teams as a people leader

🎯 Requirements

• High School degree and 12 years of experience, OR Bachelor's Degree and eight years' experience, OR Master's Degree and six years' experience, OR PhD / PharmD • Experience as independent lead managing clinical data management deliverables for regulatory filings • Experience managing NIS studies in an oversight capacity • At least 10 years of relevant industry experience with clinical trials • Successful track record of leading through influence and working across complex, global organizational matrices • Experience with Industry Standards Guidelines, such as CDISC, CDASH, SDTM, or ADaM • Strong knowledge of industry-leading EDC tools, such as Medidata Rave, Veeva EDC, Medrio EDC, Oracle, or TrialGrid • Experience interpreting Health Authority regulations and GCP/ICH guidelines • Strong working knowledge of the overall pharmaceutical development process • Influential leadership and communication capabilities • Proficiency in web-based Electronic Data Capture systems • Experience with industry-wide thesauri/dictionaries such as MedDRA and WHODD • Excellent verbal and written communication skills • Experienced project management skills • Flexible, detail-oriented, able to work under pressure, and able to take on unfamiliar tasks • Training and mentoring experience in Clinical Data Management • Potential for direct report responsibility including oversight and development

🏖️ Benefits

• Discretionary annual bonus • Discretionary stock-based long-term incentives • Paid time off • Company-sponsored medical insurance • Company-sponsored dental insurance • Company-sponsored vision insurance • Company-sponsored life insurance • Equal employment opportunity and reasonable accommodation support