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Clinical Data Manager
San Carlos, California, United States
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, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
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 conducted by Vaxcyte, from study start-up through to study closeout, ensuring high quality data deliverables which are on time and within budget.
In close collaboration with the Clinical Operations and other internal Vaxcyte teams, the Clinical Data Manager will be accountable for assisting in Clinical Data Management start-up activities across one or more vaccine trial programs. 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. The CDM Team will support the oversight of data management start-up activities through close out.
Essential Functions:
- 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.
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. Other combinations of education and/or experience may be considered.
- 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.
Reports to: Senior Director, Clinical Data Management
Location: Remote or San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $135,000 – $157,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Relocation:
This role is eligible for relocation assistance.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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