Senior Manager, Clinical Data Management

🔥 0 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 CDM strategy and processes • Build working relationships with Clinical Operations, Medical Affairs, and Translational Medicine • Communicate study-level decisions and impacts to wider study teams • Provide functional expertise during study 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 clinical data completeness, accuracy, consistency, and data structure across the program • Manage or oversee CDM deliverables • Lead CDM representation during internal and Health Authority audits • Lead development, review, and implementation of CDM processes, policies, SOPs, and related documents • Lead or participate in CDM cross-functional initiatives • Provide input into CDM organizational strategy and implement departmental change • Lead continuous improvement support and implementation within Clinical Data Management • Prioritize and delegate study and initiative responsibilities • Assume expanded responsibility for clinical project volume, complexity, and direct reports • Manage data managers and data management associates, oversee CDM vendors, and oversee project timelines and data management documentation • Train and mentor CDM staff • Communicate and escalate project-level issues involving processes, timelines, resourcing, and performance • Potentially oversee and develop direct reports

🎯 Requirements

• High School degree and 12 years of experience OR Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience OR PhD / PharmD • Experience as independent lead in 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, including 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 • Proficiency in web-based Electronic Data Capture and clinical data management systems • Experience with industry-wide thesauri/dictionaries such as MedDRA and WHODD • Experienced project management skills • Excellent verbal and written communication skills • Training and mentoring experience in Clinical Data Management • Ability to communicate and escalate project-level issues • Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks • Ability to prioritize and effectively delegate responsibilities

🏖️ 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 • Benefits package