Clinical Data Manager

March 7

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $135k - $157k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

📊 Data Scientist

🦅 H1B Visa Sponsor

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Vaxcyte

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Vaxcyte is a biotechnology company focused on developing innovative vaccines to combat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. Utilizing advanced chemistry and synthetic techniques, Vaxcyte aims to improve upon existing vaccines with products like their VAX-24 and VAX-31 pneumococcal conjugate vaccines, which target a broad range of bacterial strains. Vaxcyte's approach includes re-engineering the vaccine-making process through the XpressCF™ cell-free protein synthesis platform, aiming to create vaccines that effectively counter bacteria's complex defense mechanisms while maintaining immunogenicity. Their pipeline includes several high-fidelity, broad-spectrum vaccine candidates designed to address significant public health challenges and prevent bacterial infections worldwide.

51 - 200 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Join our Mission to Protect Humankind! • Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. • Our path to success is clear and well-defined. • The Clinical Data Manager is a key member of the Clinical team and will be responsible for assisting with the deliverable oversight and management of our Biometrics partners related activities conducted for clinical trials. • You will be responsible for assisting the Clinical Data Management (CDM) team in supporting the planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data.

🎯 Requirements

• BA/BS in life sciences, technical, or health-related field, with a minimum of 5 years of pharmaceutical industry and clinical data management experience across phase I to III clinical trials required. • In depth knowledge of industry leading eCRF tools and well versed in industry trends and emerging technologies supporting data collection as well as reviewing and contributing to all relevant DM documentation (i.e. lead CRF creation, DMP, eCRF Completion Guidelines, DTS/DTA, etc.). • Knowledge of CDISC requirements; understanding of data collection requirements is required; understanding of SDTM requirements. • Ability to develop strong and productive working relationships with internal and external key stakeholders. • Knowledge of clinical research, FDA & ICH, GCP, GCDMP, related regulatory requirements required. • General knowledge of FDA regulations that govern the execution of clinical trials and Electronic Data Capture (EDC) systems required • Expertise in CDASH/CDISC standards preferred. • Proven experience in hands on data management tasks • Able to work in a fast paced and dynamic environment while effectively managing multiple projects which may have changing priorities • Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors • Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills. • Excellent verbal and written communication skills and interpersonal skills are required.

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Equity component