Outsourcing Manager

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

San Mateo, United States US Tech Solutions Full time

True Job Title: Vendor Outsourcing, Associate

Onsite: Foster City

Hybrid: 3 days a week minimum

Contract Duration: 12 months with possible 6 months extension


The candidate will be responsible for conducting functional internal audits on behalf of Vendor Outsourcing to ensure inspection readiness. This position will also be responsible for assisting in business process improvement initiatives to maximize quality and efficiencies.


The candidate should have a deep understanding of vendor outsourcing’s responsibilities throughout the vendor sourcing, contracting, and management processes as they will be reviewing VO’s 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 VO’s electronically Trial Master File (eTMF) and Contract Repositories to ensure meticulous oversight of VO’s documentation, 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.


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 team’s success

• Strong project management, organization, and critical thinking skills

• Comfortable interacting with internal stakeholders and external vendors

• Executive presence

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