Job Description

Overview

As a Program you will be joining the world\xe2\x80\x99s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Clinical budget oversite. A large portion of this role is involved in managing the project budget for the study they\xe2\x80\x99re assigned. Creation and maintenance.

• CRO and vendor management (management is key): They have to be responsible for managing the vendors and CROs that Seagen utilizes on the projects. Labs, Monitoring, Recruitment\xe2\x80\xa6multiple vendors. Not just one specialized area of oversite.

• Driving the conduct of the study and working \xe2\x80\x9cinternally\xe2\x80\x9d with the different teams
• Global study experience is required almost all the time
• Reviews study metrics for performance and quality with the team and management.
• Ensures review of Clinical Trial Master File for completeness.
• Negotiates and manages competing priorities across multiple functional areas.
• Manages and coordinates all vendors involved in the clinical trials, e.g. central lab, CROs, including managing the RFP processes and overall budget for each.
• Prepares high-quality reports (financial, project, etc.) for management on program status and issues.
• Proactively manages cross functional project teams derived from the groups within clinical development to deliver a high quality clinical trial(s).
• Assists in developing protocol overview (study design, entry criteria and schedule of activities table). Reviews protocol and CRFs and tracks development to completion.
• Creates project budgets and manages cost to budgets. Develops enrollment projection, and drug supply needs as part of the budget.
• Responsible for creating and maintaining MS Project timelines for each project, and uses these timelines to track and manage a project\xe2\x80\x99s progress.
• Responsible for creating Project Plans (e.g. Responsibility Table, and Communication Plans) for each project.
• Reviews study-related support materials created by the Monitoring and Data Management Groups (e.g. study manual, monitoring plan, edit check manual, Listing Review process).
• Responsible for clinical trial team meetings.
• Highly effective organizational and communication skills
• Knowledge of CFR and GCP/ICH requirements is required, as well as European Clinical Trial Directive knowledge is preferred.
• Demonstrated leadership skills and the ability to solve problems proactively
• Willingness to travel approximately 10%
• Proficiency with Excel, MS Project, Contract development and vendor oversight. CRO management experience a plus.
• Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term objectives of the Company
• Project Management Certification (PMP) is a plus

Qualifications

You are:

BA/BS or equivalent is preferred with a minimum of 6 years (for CPM) & 8 years (for Sr. CPM) of pharmaceutical or biotech research experience

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That\xe2\x80\x99s why we are committed to developing our employees in a continuous learning culture \xe2\x80\x93 one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless \xe2\x80\x93 there\xe2\x80\x99s every chance you\xe2\x80\x99re exactly what we\xe2\x80\x99re looking for here at ICON whether it is for this or other roles.

ICON