Clinical Operations Specialist - net2source : Job Details

True Job title: Vendor Qualification Associate - Clinical Operations

Duration: 12 months

Location: Foster City, CA 94404

Pay: $ 40 - 42.85/hr on W2

Hybrid Role (3 days onsite/2 days remote)

Top 3 Required Skill Sets: 1) R&D Clinical Procurement Experience (2) Candidates can be current or former project managers & (3) Deep understanding of Quality and Compliance across Pharmaceutical or Healthcare industries and Excel

Top 3 Nice to Have Skill Sets: Vendor Outsourcing, Subcontractor Management, Vendor Contracting and System skills ( Veeva, RDMS,TMF etc.)

Job Description

The candidate should have a deep understanding of vendor capability assessments, sourcing, contracting, procurement, category management, and inspection readiness activities as they will be leading and/or supporting those cross-functional efforts. The candidate should also have an understanding of various clinical trial activities such as clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.

Daily Activities

Daily activities will include, but are not limited to:

• Conducting Request for Information (RFI)
• Data Privacy and Security IT Assessments
• Anti-Bribery and Anti-Corruption Due Diligence
• Financial Health Assessments
• Inspection Readiness Preparation Activities
• Data Analyses and Benchmarking to Provide Data Informed Insights into Strategies and Continuous Improvement Initiatives
• Presentations and Trainings

Qualifications and Skills

The candidate should have:

• Executive presence
• Project management & critical thinking skills
• Comfort in interacting with internal stakeholders and external vendors

The Vendor Qualification Associate I will be regularly partnering with team members such as:

• R&D Quality & Compliance
• Clinical operations
• Finance
• Legal
• Business conduct
• Payments

The Vendor Qualification Associate I is expected to:

• Complete tasks and projects under minimal supervision
• Manage competing priorities effectively and proficiently

Compliance Knowledge

Demonstrates a thorough knowledge of:

• Good Clinical Practice (GCP)
• Good Pharmacovigilance Practices (GVP)
• Good Laboratory Practice (GLP)
• Good Documentation Practice (GDP)
• ICH E6 R2 compliance requirements

Demonstrates a thorough understanding of current global and regional trends in compliance.

Experience Requirements

Candidate has:

• 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry
• BS or BA degree
• (1) PMP certification or equivalent certification
• (2) Candidates can be current or former project managers
• (3) Project management experience in Pharmaceutical or Healthcare industries

Skills

• Strong interpersonal communication skills
• Attention to detail and proactive management of quality findings will be integral to the team's success
• Strong project management, organization, and critical thinking skills
• Comfortable interacting with internal stakeholders and external vendors
• Executive presence

Required Years of Experience

• 3-5 years

Unique Selling Point of This Role

• Growth Mindset
• Proactive Leader to drive initiatives
• Strong written and Verbal Communication skills
• Able to thrive in a dynamic work environment

Seniority level

• Seniority levelAssociate

Employment type

• Employment typeContract

Job function

• Job functionBusiness Development, Science, and Consulting
• IndustriesPharmaceutical Manufacturing, Biotechnology Research, and Research Services

Referrals increase your chances of interviewing at Net2Source Inc. by 2x

Get notified about new Clinical Operations Specialist jobs in Foster City, CA.

Clinical Trial Assistant I, Clinical OperationsClinical Trial Assistant I, Clinical OperationsClinical Trial Assistant I, Clinical Operations

San Mateo County, CA $40 - $45 2 weeks ago

South San Francisco, CA$115,500.00-$140,000.002 weeks ago

San Francisco, CA$100,000.00-$115,000.001 month ago

Hayward, CA$80,000.00-$95,000.006 days ago

Strategy and Operations Lead - Clinical Care

San Francisco, CA$150,000.00-$170,000.002 days ago

Alameda, CA$72,100.00-$114,700.002 hours ago

Alameda, CA$72,100.00-$114,700.001 day ago

Senior Clinical Trial Management Associate

South San Francisco, CA$128,000.00-$160,000.003 weeks ago

Alameda, CA$72,100.00-$114,700.001 day ago

Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)

San Francisco, CA $70,000 - $160,000 1 day ago

CRA III (Associate Clinical Research III)

Alameda, CA $86,700 - $173,300 13 hours ago

Clinical Operations Therapeutic Area Leader - Cardiovascular, Renal & Metabolism

Santa Clara, CA $79,200 - $148,500 3 days ago

Fremont, CA $89,000 - $148,000 6 months ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr