Clinical Vendor Outsourcing associate - San Mateo, United States - Intelliswift Software Inc
Description
Title: Clinical Contracts Associate I (VQ Associate I)
Location: Foster City
Duration: 12 Months on W2
Hybrid: 3 days a week minimum
Details:
The candidate should have a deep understanding of vendor outsourcings responsibilities throughout the vendor sourcing, contracting, and management processes as they will be reviewing VOs functional responsibilities in support of the clinical development portfolio. Thus, the candidate should also have an understanding of various clinical trial activities such as Clinical Trial Management Services, 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 will include, but are not limited to, working within a team environment and leading functional internal audits of VOs electronical Trial Master File (eTMF) and Contract Repositories to ensure meticulous oversight of VOs documentations, adherence to work procedures, compliance standards, and the preservation of data integrity.
The role also involves coaching VO team members to resolve issues from a QC standpoint and serving as a primary reviewer of QC data for inspection readiness.
The VO QC Specialist is expected to complete tasks and projects under minimal supervision and has the ability to manage competing priorities effectively and proficiently.
Demonstrates a thorough knowledge of Good Clinical Practice GCP, Good Pharmacovigilance Practices GVP, Good Laboratory Practice GLP, Good Documentation Practice GDP and ICH E6 R2 compliance requirements.
Demonstrates a thorough understanding of current global and regional trends in compliance. Candidate has 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry; and, has a BS or BA.(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 teams success
Strong project management, organization, and critical thinking skills
Comfortable interacting with internal stakeholders and external vendors
Executive presence