Clinical Data Manager

Summary

Join Vaxcyte, a clinical-stage vaccine innovation company, as a Clinical Data Manager! This key role involves overseeing and managing Biometrics partners' activities for clinical trials, ensuring high-quality data deliverables on time and within budget. You will collaborate with Clinical Operations and internal teams, assisting in Clinical Data Management start-up activities across vaccine trial programs. Responsibilities include ensuring DM deliverables meet expectations, managing documentation, overseeing CROs and vendors, reviewing documents, assisting with investigator meetings and trainings, tracking DM activities, and coordinating team meetings. The ideal candidate possesses a BA/BS in a relevant field with 5+ years of pharmaceutical industry and clinical data management experience across Phase I-III trials. A competitive compensation package, including comprehensive benefits and equity, is offered.

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
• 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

Responsibilities

• Ensures DM deliverables provided by CRO partners meet/exceed project/study team expectations regarding quality, time and cost
• Ensures DM documentation is filed/archived according to applicable company and regulatory requirements
• Provides assistance with oversight for DM CROs and other third-party vendors who provide clinical study data to ensure compliance with the protocol, external/internal procedural standards, GCP, applicable regulatory guidelines, company policies, SOPs and other relevant guidelines
• May act as the primary liaison with DM CROs, third party vendors and EDC vendors for study work
• Reviews clinical study related documents from a data management perspective (e.g. protocol) and approves DM specific documents (e.g. Data Management Plan, Data Review Plan, CRF Completion Guidelines, etc.)
• Assist clinical study team with the planning, preparation, and on-site support of investigators meetings and CRA trainings
• Assist with tracking of status of DM related activities (e.g. EDC setup, data cleaning, coding, etc.)
• Assist with final sign off of project and study-related documents including: Edit Check Specifications, CRF Completion Guidelines, Data Transfer Agreements, etc
• Coordinate and participate in team meetings/teleconferences/Zoom including preparation of agendas, minutes and tracking action items
• Be an outstanding teammate

Preferred Qualifications

Expertise in CDASH/CDISC standards preferred

Benefits

• Competitive compensation package
• Comprehensive benefits
• Equity component
• Salary Range: $135,000 – $157,000 (SF Bay Area)
• Salary ranges for non-California locations may vary