Full-Time Clinical Data Manager

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. Working to eradicate or treat bacterial infections is just the beginning.

Our path to success is clear. WHAT we do is every bit as important as HOW we do it!

Our work is guided by four enduring core values:

• RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work.
• AIM HIGH: We embody our audacious goal.
• LEAD WITH HEART: Everyone leads with a kindness-first, inclusive approach.
• MODEL EXCELLENCE: We commit to integrity, accountability, equality, and clarity.

The Clinical Data Manager is a key member of the Clinical team responsible for assisting with the deliverable oversight of Biometrics partners for clinical trials, from study start-up to closeout, ensuring high-quality data on time and within budget. In close collaboration with Clinical Operations and other teams, the Clinical Data Manager will assist in Clinical Data Management start-up activities across vaccine trial programs.

Essential Functions:

• Ensures data deliverables meet/exceed project expectations regarding quality, time, and cost.
• Ensures documentation is filed/archived according to company and regulatory requirements.
• Provides oversight for DM CROs and third-party vendors for protocol compliance, standards, GCP, regulatory guidelines, company policies, SOPs, and other guidelines.
• May act as the primary liaison with DM CROs, third party vendors and EDC vendors.
• Reviews clinical study documents (protocol) and approves DM specific documents (Data Management Plan, Data Review Plan, CRF Completion Guidelines, etc.).
• Assists clinical study team with investigator meetings and CRA trainings.
• Assists with tracking of DM activities (EDC setup, data cleaning, coding, etc.).
• Assists with final sign-off of project documents (Edit Check Specifications, CRF Completion Guidelines, Data Transfer Agreements, etc.).
• Coordinates and participates in team meetings/teleconferences, including preparing agendas, minutes, and tracking action items.
• Be an outstanding teammate.

Requirements:

• BA/BS in life sciences or related field, minimum 5 years of pharmaceutical industry and clinical data management experience across Phase I-III clinical trials.
• In-depth knowledge of eCRF tools and industry trends.
• Knowledge of CDISC requirements, data collection requirements, and SDTM requirements.
• Strong working relationships with internal and external stakeholders.
• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, related regulatory requirements.
• Knowledge of FDA regulations and EDC systems.
• Expertise in CDASH/CDISC standards (preferred).
• Proven hands-on data management experience.
• Ability to work in a fast-paced environment and manage multiple projects.
• Excellent teamwork, organizational, interpersonal, conflict resolution, problem-solving skills.
• Excellent communication skills.

What is the last date for applying to the job?

Which countries are accepted for this remote job?