Clinical Data Manager

Vaxcyte, Inc.; San Carlos (CA); Hybrid; USD 135,000 - 157,000; Full time

Job summary

An innovative company is seeking a Clinical Data Manager to play a pivotal role in overseeing clinical trial data management. This position involves ensuring high-quality data delivery while collaborating with various teams to support vaccine trial programs. The role requires a deep understanding of clinical data management, industry regulations, and strong relationship-building skills. Join a mission-driven team committed to protecting humankind through groundbreaking vaccine innovations. This position offers competitive compensation and the flexibility to work remotely or from the San Carlos office.

Benefits

Relocation Assistance

Equity Options

Health Benefits

Flexible Work Environment

Qualifications

• 5+ years of clinical data management experience across phase I-III trials.
• Deep knowledge of eCRF tools and industry trends.

Responsibilities

• Oversee deliverables and manage biometrics activities for clinical trials.
• Ensure DM deliverables from CRO partners meet quality and time expectations.

Skills

Clinical Data Management

eCRF Tools

CDISC Standards

FDA Regulations

Teamwork

Problem-Solving

Education

BA/BS in Life Sciences

Tools

EDC Systems

Job description

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases with serious health consequences. Our focus includes eradicating or treating infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

What we do is as important as how we do it! Our work is guided by four core values:

• Rethink Convention: We bring creative and intellectual diversity to innovate vaccine delivery.
• Aim High: We aim to make the most complex biologics to protect humankind.
• Lead with Heart: We foster kindness, inclusivity, and vigorous debate to advance our objectives.
• Model Excellence: We demonstrate integrity, accountability, and clarity in communication and decision-making.

Summary: The Clinical Data Manager is a key member of the Clinical team, responsible for overseeing deliverables and managing biometrics activities for clinical trials from start-up to closeout, ensuring high-quality, timely, and budget-conscious data delivery. Collaborating closely with Clinical Operations and other teams, this role supports clinical data management start-up activities across vaccine trial programs and ensures the planning, coordination, and delivery of reliable clinical trial data.

Essential Functions:

1. Ensure DM deliverables from CRO partners meet quality, time, and cost expectations.
2. File and archive DM documentation according to company and regulatory standards.
3. Assist oversight of DM CROs and vendors for compliance with protocols, standards, GCP, and regulations.
4. Act as primary liaison with DM CROs, vendors, and EDC vendors.
5. Review and approve clinical study documents from a data management perspective.
6. Support clinical study team with planning, investigator meetings, and CRA trainings.
7. Track the status of DM activities like EDC setup, data cleaning, and coding.
8. Assist with final sign-off of project and study documents.
9. Coordinate team meetings, prepare agendas, minutes, and track actions.
10. Be an outstanding teammate.

Requirements:

• BA/BS in life sciences, health, or related field, with at least 5 years of clinical data management experience across phase I-III trials. Other combinations of education and experience may be considered.
• Deep knowledge of eCRF tools, industry trends, and emerging technologies in data collection.
• Understanding of CDISC, SDTM, and data collection requirements.
• Strong relationship-building skills with internal and external stakeholders.
• Knowledge of clinical research regulations, FDA, ICH, GCP, GCDMP.
• Experience with FDA regulations governing clinical trials and EDC systems.
• Proficiency in CDASH/CDISC standards preferred.
• Hands-on data management experience.
• Ability to manage multiple projects in a fast-paced environment.
• Excellent teamwork, organizational, communication, and problem-solving skills.

Reports to: Senior Director, Clinical Data Management

Location: Remote or San Carlos, CA

Compensation: Competitive salary with benefits and equity, ranging from $135,000 to $157,000 (SF Bay Area). Non-California salaries may vary. Relocation assistance available.

We are an equal opportunity employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.