Study Start Up Analyst

Study Start Up Analyst

This position performs assigned activities within the Clinical Trial Logistics Study Start-up team (CTL SSU). Responsibilities include but are not limited to: providing support to CTL SSU; creating/managing relationships with investigative sites while building efficiencies across various Incyte clinical trial programs to effectively start the clinical programs.

Job Responsibilities

• Assist in the development and negotiation of Master Clinical Trial Agreements (MCTAs) and site budget rate cards with investigative sites;
• Oversee essential documents collection, tracking and review to support the activation of sites across multiple studies
• Serve as a site liaison, identify and build efficiencies across various Incyte clinical trial programs;
• Develop and manage a site intelligence repository in the CTL SSU tool; enables team members to track and update activities within the tool
• Provide support to CTL SSU as needed including liaising with sites to negotiate contracts and budgets and collection of essential regulatory documents;
• Develop metric dashboards and report quarterly metrics and KPIs;
• Manage repository of site start up processes (institutional and investigators) to maintain consistency in start-up processes; and
• Maintain consistent communications with internal clients, and study team members to expedite site activation.

Minimum Requirements

• Bachelor’s Degree in business administration, finance, science or related field;
• Minimum of five years of relevant experience in the biopharmaceutical/CRO industry; and
• Minimum of five years negotiating US Site contracts and budgets
• Excellent negotiation skills;
• Experience with conflict resolution;
• Proven ability to effectively manage change;
• Experience with review and collection of essential documents required for site initiation;
• History of establishing relationships with sites;
• Ability to negotiate complex contract and payment terms;
• Flexibility to assume a workload which frequently necessitates an adjustment of priorities;
• Goal oriented, self-starter with proven ability to work independently;
• Able to proactively identify issues and provide potential solutions for resolution;
• Detail oriented;
• Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines;
• Proficiency with Grant Plan and all applications of Microsoft Office;
• Preferred experience with Veeva Vault;
• Good interpersonal skills; and
• Comfortable with ambiguity; ability to act without having the total picture