Study Start Up Manager

***Immediate Need of an ONCOLOGY STUDY START UP MANAGER***

Oncology Experience and LEAD Site Activation Experienced NEEDED

• The SSU Manager will work within the oncology therapeutic area.
• Responsibilities include but are not limited to activities such as Reg Doc collection, Binder assembly and shipment, and ensuring that all requirements for site activation are in place for the agreed number of centers in clinical studies according to Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations.

**Must Haves REQUIREMENTS**

*2+ years minimum LEADING Site Activation Experience (must be their full time job - not partial mix of maintenance or close out)

*Prefer at least 4 years of leading Site activation if it wasn't most recent.

*Experience working within Veeva Vault eTMF of at least six-months experience within the last year

*ICF Review / Approval - 2 years+ experience of as final signoff / approval from a SSU team perspective

*Intermediate Excel Experience (will track documents and stats within excel so must be able to filter, sort, basic formulas, and basic pivot tables)