Actalent Study Start Up Manager in WILMINGTON, Delaware
I am working with a global pharmaceutical company that is looking for a Study Start Up Manager to join their team! This is a fully remote opportunity. Please apply if qualified and interested!
Within this role, SSU Manager will work closely with client assigned Monitors, Support Services, Research sites and the Local Study Delivery Team to ensure that quality and quantity site activation deliverables are achieved in a timely and efficient manner.
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.
This individual will actively participate in local Study Delivery Team meetings and work cross functionally with Contracts, Feasibility and Study Support Services to accomplish the above.
Additional Skills & Qualifications:
*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 - 2 years+ experience
*Intermediate Excel Experience (will track documents and stats within excel so must be able to filter, sort, basic formulas, and basic pivot tables)
Soft Skills Preferred:
*Ability to work independently and with high accountability to ensure sites are activated with all proper documents
*Be a self starter while also understanding when to consult for advice and when to make best decision on their own
*Ability to manage competing priorities -- may be working with multiple studies and need to know which actions need to be prioritized first
*Someone who won't be shy to get creative to track down response and follow up from sites that aren't fully cooperative
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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