Clinical Contracts Associate - I
LeadStack Inc Foster City, CA
- Posted: 25 days ago
Locations : Morris Plains, NJ, Foster City, CA or Santa Monica, CA
The Development Business Operations Clinical Contract Manager I will report to the Director, Development Business Operations and is responsible for managing the clinical outsourcing and contracting of global projects or Phase I-IV clinical trials, which may include functional service providers, CROs, clinical monitoring, data management, biostatistics, medical writing, Phase 1 CRUs, central labs, biomarker labs, bioanalytical labs, RTSM, eCOA, medical imaging, safety, regulatory affairs, medical affairs, e-informed consent, mobile HCP services, telemedicine, translations and wearables/sensors.
The Clinical Contract Manager I may assist the Vendor Qualification Manager with vendor assessments in the Development Business Operations group including, but not limited to, Vendor Qualifications, IT Security Assessments, Anti-Bribery and Anti-Corruption Due Diligence.
The Clinical Contract Manager I may also assist with other projects in the Development Business Operations group including, but not limited to, Category Reviews, Spend Analysis, Supply Market Analysis, MSA Amendments, Inspection Readiness, Remediations, CAPAs, TMF Reviews, and Standard Operating Procedures "SOPs .
The Clinical Contract Manager I will assist in the entire life cycle of vendor selection, including RFI, RFP, vendor selection decision, contracting, monitoring performance, managing the change order process, and ensuring the proper closeout of agreements.
The Clinical Contract Manager I will work with other Clinical Contract Managers, Vendor Selection Teams, Vendor Qualification Manager and internal customers in the vendor qualification process, vendor selection process, vendor bidding and proposal development (RFI/RFP creation and analyses), contracting and may assist with the planning of vendor capabilities presentations during the vendor bid defense meetings. Assists other Development Business Operations staff in resolving moderately complex issues relating to contract negotiation or management as related to vendor contracts and with the support of internal customers and the legal department, assists in the contract negotiation process. The Clinical Contract Manager I has excellent communication, project management & critical thinking skills; and, is comfortable interacting with internal and external teams, such as, R&D Quality & Compliance, clinical operations, finance, legal, business conduct, vendor relationship management, payments, and vendors. Completes tasks and projects under minimal supervision and has the ability to manage competing priorities effectively and proficiently.
Demonstrates knowledge of Good Clinical Practice "GCP , Good Pharmacovigilance Practices "GVP , Good Laboratory Practice "GLP , Good Documentation Practice "GDP and/or ICH E6 R2 compliance requirements. Demonstrates an understanding of current global and regional trends in clinical outsourcing and contracting. Candidate has 6+ years of relevant experience in the pharmaceutical or bio-pharmaceutical industry; and, has a BS or BA with 4+ years of relevant experience.
AddressFoster City, CA
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