Senior Manager, Clinical Outsourcing needed for a direct hire opportunity with Yoh's client located in Woodcliff, NJ.
The Big Picture - Top Skills You Should Possess:
- BA/BS in scientific or
- Direct experience (5 yr. minimum) in managing clinical contracts within the pharmaceutical industry within a clinical procurement/outsourcing function to include experience in the negotiation of contracts with Phase I-IV CROs, technical service providers, consultants etc.
- Demonstrates business/financial acumen and thorough understanding of CRO cost models and budget as well as services and costs associated with functional service providers (e.g. IVR, Central Labs, Biostatistics, and Medical Writing, Imaging, ECG, ePRO).
What You'll Be Doing:
- Support PCUs/CFUs in the development of outsourcing requirements for Phase I-IV global clinical trials including functional services
- Lead and support the qualification and evaluation process for new service providers
- Lead the process of Request for Proposal (RFP) development from service provider selection through final contract execution
- Manage the contracting activities including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments
- Negotiate services descriptions, budgets and payment schedules using costing tools as necessary
- Facilitate study kickoff/familiarization meetings to clarify timelines, statement-of-work, roles and responsibilities, and budgets
- Support project teams in the resolution of service provider
What You Need to Bring to the Table:
- Must have excellent written and oral communication skills
- Team player able to form strong cross-functional relationships, demonstrating an ability to influence/persuade others
- Flexible and proactive
- Excellent analytical and problem solving skills
- Eye for detail
- Highly organised with strong negotiation skills
- Must have good leadership and project management skills
- Thorough knowledge of GCP/ICH Guideline and Regulations
- Clear understanding of the drug development process
- Displays independent thinking and good judgment
- Proficiency in MS Office Suite
What's In It For You?
- Work for a multinational pharmaceutical and biologics company having a portfolio of products for major disease areas including cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation.
What are you waiting for? Apply Now!
Recruiter: Stephanie Tulloch
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Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.
J2W: CLINICAL; J2W: SCIENTIFIC; MONJOB
TAX TERM: FULLTIME