Clinical Risk Evaluation Project Manager

Santa Clara, CA, US • Posted 1 day ago • Updated 1 day ago

Contract W2

Contract Corp To Corp

On-site

Depends on Experience

Fitment

Dice Job Match Score™

👤 Reviewing your profile...

Job Details

Skills

Analytical Skill
Attention To Detail
Clinical Research
Collaboration
Communication
Conflict Resolution
Continuous Improvement

Summary

We are looking for Clinical Risk Evaluation Project Manager for our client in Santa Clara, CA

Job Title: Clinical Risk Evaluation Project Manager

Job Location: Santa Clara, CA

Job Type: Contract

Job Overview:

Pay Range: $52.14hr - $57.14hr

Provide cross-functional support to ensure clinical safety and residual risk information is aligned across product documentation throughout the product lifecycle.
Support compliance with quality management systems and regulatory submission requirements.
Manage clinical risk documentation and ensure consistency across all related materials.
Work in a fast-paced environment handling multiple projects and timelines.

Experience:

5+ years of experience in healthcare, clinical research, medical writing, or related fields within the medical device or pharmaceutical industry.

Responsibilities:

Write and manage product master files related to clinical risks, adverse events, and safety information.
Lead and participate in the clinical risk evaluation process across the product lifecycle.
Create and maintain Risk Evaluation Files for medical device products.
Lead Risk Alignment Committee meetings and collaborate with cross-functional stakeholders.
Facilitate and document decision-making processes with proper rationale.
Identify, interpret, and evaluate clinical safety data from various sources including clinical studies, post-market data, and scientific literature.
Review and ensure alignment of clinical risk information across documents such as Instructions for Use, clinical reports, and safety updates.
Support global regulatory submissions and maintain communication with regulatory stakeholders.
Assist in responding to regulatory authorities, ethics committees, and review boards.
Maintain knowledge of assigned products and therapeutic areas.
Support continuous process improvement initiatives.
Ensure compliance with corporate policies, procedures, and regulatory guidelines.

Skills:

Strong communication and collaboration skills.
Technical writing expertise.
Ability to manage multiple priorities effectively.
Analytical and problem-solving skills.
Attention to detail and accuracy.

Qualification And Education:

Bachelor s degree required.
Advanced degree in medicine, nursing, or biomedical science preferred.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10516350
Position Id: CA_CREP_0325
Posted 1 day ago

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Biostatistician 4

Mountain View, California

•

Today

Primary Function of Position As a key member of the Clinical Affairs department, the Senior Biostatistician (Biostatistician IV) provides advanced statistical expertise to support the design, conduct, and analysis of clinical studies, ranging from early pre-market to post-market evidence generation. The Biostatistician IV is the statistical subject matter expert working in cross-functional teams, managing roadmaps and priorities to ensure timely and high quality delivery of results. This role s

Easy Apply

Third Party, Contract

$80 - $93

Clinical Operations Lead

South San Francisco, California

•

Today

Software Guidance & Assistance, Inc., (SGA), is searching for a Clinical Operations Lead for a CONTRACT assignment with one of our premier Pharmaceutical clients in South San Francisco, CA. Responsibilities: As a Clinical Operations Lead in a cross-functional, matrixed organization, you will be empowered to work with people across PDG and beyond to enable all teams to perform at their best, foster a growth mindset to optimize potential and talent, and flow to high impact work to advance our

Contract

USD 55.22 - 81.72 per hour

Director, Gen AI, Digital Health

Mountain View, California

•

Today

Lab Summary: Our mission is to empower people to live healthier lives by leveraging our wearables, smartphones, medical devices, AI, and health services. We research, develop, and commercialize innovative digital health products and solutions by bringing together the full capabilities of our team, including product strategy and management, clinical expertise, partnerships, UI/UX design, usability research, clinical research and validation, software development, AI / Gen AI, and regulatory. Mill

Full-time

USD 235,400.00 - 365,650.00 per year

Clinical QC Consultant

Remote

•

6d ago

Position Overview The Clinical QC Consultant is responsible for ensuring the quality, accuracy, and compliance of clinical trial documentation and data. This role supports clinical operations by performing quality control reviews and ensuring adherence to regulatory requirements and internal standards. Key Responsibilities Perform QC review of clinical documents, including:Clinical study reports (CSRs)Protocols and protocol amendmentsInformed consent forms (ICFs)Monitoring visit reportsTrial mas

Easy Apply

Contract

Depends on Experience

Search all similar jobs