Site Activation Lead

Employer
ICON Clinical Research
Location
Warsaw
Salary
Competitive
Closing date
9 Oct 2020

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Discipline
Clinical Research, Clinical Trials Manager / Administrator
Hours
Full Time
Contract Type
Permanent
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Job Title: Site Activation Lead

Location: Warsaw, Poland

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them?

At ICON, we have an incredible opportunity for a Site Activation Lead to join the team.

The Role:

The Site Activation Lead is responsible for ensuring the successful and timely activation of investigative sites to ensure that sites are activated in line with the study timelines and client expectation. The Site Activation Lead provides oversight for activities associated with substantial amendments as required. The Site Activation Lead is the functional representative of the Study Start Up department at the project team level.

Client Relationship:
  • Prepare/contribute to client and project specific site activation strategy and site activation plan and work cross-functionally to ensure that the sites and countries chosen optimize opportunities for successful delivery of the project for the benefit of the client and of ICON.
  • Ensure adequate oversight of project in terms of timely delivery of key timelines and that the impact of missed deliverables is understood by all key stakeholders.
  • Attends client calls, where required and ensures that both the interests of the client and of ICON are robustly defended.
  • Solicits the engagement and the contribution of key study stakeholders to ensure optimum performance and cross-collaboration.
  • Creates and maintains an environment of "trusted partner" which allows successful delivery of site activation through clear and open dialogue and use of "best practice" communication.
  • Invokes lessons learned and defines and uses other strategies/tools as required to assure optimized delivery and client satisfaction.
  • Support sales preparation materials and calls including bid-defense and study kick-off meetings where required.


Operations Management:
  • Oversees day to day delivery of all aspects of site activation in the projects assigned.
  • Ensures that each project has a site activation plan and that the study is being conducted in accordance with that plan and in an effective manner which meets sponsor timelines and expectations and is in compliance with ICON/client KPIs, ICON/client SOPs, reporting norms, appropriate regulations and ICON's quality standards
  • Ensure that tasks associated with substantial amendments during the site activation and maintenance phase of the clinical trial are being coordinated and reported to a high standard and to the client satisfaction
  • Ensure effective resource planning and allocation within projects assigned.
  • Works with relevant management to ensure effective utilization and recovery of site activation resources within projects assigned and that those resources are budgeted and contracted.
  • Effectively embrace and foster change with respect to process improvement initiatives across site activation.
  • Works closely with peers to ensure global consistency in the successful execution of site activation activities & services across the SSU function.
  • Ensures that study performance is objectively & systematically measured and reviewed on a regular basis & reports status to relevant management
  • Manages and escalates any significant variations to study budgets, identifies out of scope activities and ensures to input into change orders as required.
  • Other duties as assigned.

What you need
  • Bachelors' degree or local equivalent in medicine, science, or equivalent.
  • Experience in oversight of study deliverables, ideally with proven experience in the oversight of site activation project phase and/or staff in a global/multi-regional environment & familiar with GCP requirements
  • In-depth experience within clinical research with experience in the Clinical studies regulatory environment and a leadership role.
  • Significant leadership and well developed managerial skills demonstrating the following key Competencies:
  • Critical thinker and solution focused
  • Proactive & Delivery focused
  • Client focused
  • Excellent planning and organizational ability
  • Proven decision making capabilities, analytical and data focused
  • Team focused & collaborative
  • Excellent negotiation & relationship building skills
  • Excellent conflict management skills
  • Excellent communication skills with demonstrated coaching and mentoring skills
  • Ability to successfully manage, positively interact and liaise successfully with all levels of staff at ICON, vendors, and clients.
  • Due to the nature of this position it may be required for the employee to travel, including air travel. Therefore, dependent on the employees' location, the employee may be required to possess a valid Drivers' license

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

We are a global provider of outsourced development and commercialisation services to pharmaceuticalbiotechnologymedical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

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