What are the responsibilities and job description for the Vendor Oversight Manager position at Seqirus A CSL Company?
We have an exciting opportunity for an experienced dynamic Vendor Oversight Manager to be based at any of our US (Cambridge, NC, NJ) or EU (Amsterdam or Maidenhead UK) Hubs. The Vendor Oversight Manager will support the development and execution of the Clinical Development Vendor Management framework and governance, from selection of external partners through discontinuation. Develops and maintains liaison with key vendors. Determines and monitors vendor performance and actively participates in Vendor Management/Oversight activities.
As the Vendor Oversight Manager, your key accountabilities will include:
- Lead or play a key role in the collaboration of functional and quality partners, to determine the appropriate level of quality governance for ClinDev vendors and vendor engagement.
- Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory requirements
- Support the negotiation of CDAs, contractual terms, rate cards, and other contractual items with all vendors. Drive ownership of all deliverables through effective oversight and governance of the vendors.
- Ensure all study level activities provided by vendor are successfully delivered based on the requirements of the Master Services agreement and relevant task orders, appropriate regulatory standards, and within the agreed timeframe and budget
- Partners with functional, procurement, finance, business operations and quality teams to define ongoing and pragmatic vendor oversight approaches for ClinDev vendors.
- Ensures contracted vendors comply with national and international regulations, such as GxP guidelines and/or any other relevant international and national legislation(s), regulations(s), and guidance(s) as well as company policies and procedures in area of responsibility
- Develop and monitor robust vendor performance metrics across contracted Clinical Development activities. Translate data and insights across programs and activities supported by a vendor into a coherent profile of vendor performance and compliance
Your qualifications, skills and experience
- Bachelor’s degree, or equivalent, in Science related discipline preferred
- 5 years relevant clinical research (or related) experience within the pharmaceutical industry
- A solid understanding of the drug development process, and specifically, each step within the clinical trial process
- Experience in overseeing vendors or alliance relationships for global clinical trials (CRO, pharmaceutical or research institute)
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
- Budget forecasting and management experience
- Key Performance and risk analysis
- Continuous Improvement Mindset
About Seqirus
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about
Seqirus
.
We want Seqirus to reflect the world around us
As a global organisation with employees in 35 countries, CSL embraces diversity, equity and inclusion. Learn more about
Diversity, Equity & Inclusion
at Seqirus.
Do work that matters at Seqirus!
Our Benefits
Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the
benefits
you can participate in when you join Seqirus.
About Seqirus
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about
Seqirus
.
We want Seqirus to reflect the world around us
As a global organization with employees in 35 countries, CSL embraces diversity and inclusion. Learn more about
Diversity & Inclusion
at Seqirus.
Do work that matters at Seqirus!
Vendor Start-Up Manager – IRT
5PY US Quintiles, Inc. -
Durham, NC
Manager Vendor Risk Management 1LoD
Royal Bank of Canada> -
Raleigh, NC
Manager, Financial Crimes Oversight Testing U.S.
RBC -
Raleigh, NC