Clinical Contracts Associate - I
About The Position
Client is looking for a Vendor Qualification Associate I, who will report to the Director of Vendor Outsourcing. The candidate will be responsible for ensuring high quality of data and services across all vendors supporting global R&D portfolio – Ph I-IV clinical trials. 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 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.
Requirements
- BS or BA with 5 years of relevant experience.
- PMP certification or equivalent certification.
- Executive presence.
- Excellent communication skills.
- Project management skills.
- Critical thinking skills.
- Comfortable interacting with internal stakeholders and external vendors.
- Ability to complete tasks and projects under minimal supervision.
- Ability to manage competing priorities effectively and proficiently.
- 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.
- Thorough understanding of current global and regional trends in compliance.
- 10 years of relevant experience in the pharmaceutical or biopharmaceutical industry.
- Current or former project managers.
- Project management experience in Pharmaceutical or Healthcare industries.
Nice To Haves
- Deep understanding of vendor capability assessments, sourcing, contracting, procurement, category management, and inspection readiness activities.
- 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.
Responsibilities
- Ensuring high quality of data and services across all vendors supporting global R&D portfolio – Ph I-IV clinical trials.
- Leading and/or supporting cross-functional efforts in vendor capability assessments, sourcing, contracting, procurement, category management, and inspection readiness.
- Conducting Request for Information (RFI).
- Conducting Data Privacy and Security IT Assessments.
- Conducting Anti-Bribery and Anti-Corruption Due Diligence.
- Conducting Financial Health Assessments.
- Conducting Inspection Readiness Preparation Activities.
- Performing Data Analyses and Benchmarking to Provide Data Informed Insights into Strategies and Continuous Improvement Initiatives.
- Giving Presentations.
- Conducting Trainings.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
