Site Activation Lead

ICON plc (Salzburg, Österreich) Vor 28 Tagen veröffentlicht

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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 Senior Site Activation Lead to join the team.

The Role:

As the single-service project manager during the site startup phase of the project, the Senior Site Activation Lead (Snr SAL) is accountable for driving and accelerating the activation of investigative sites in line with, or ahead of, the study's contractual timelines, budgeted resources, quality output, and sponsor expectation. The Senior SAL is accountable for the overall coordination, implementation and completion of site activation activities for large global or complex projects of work in line with ICON/sponsor SOPs as appropriate. The Senior SAL is expected to interact with internal teams, as well as sponsor teams; as well as present to Exec Management

  • Primary study start up point of contact for designated complex and/or global projects.
  • Accountable for developing successful working relations with sponsors, as evidenced by high sponsor satisfaction scores in SSU, to ensure repeat business.
  • Defines project scope, including resource requirements and deliverables, from a study start up perspective.
  • Accountable for writing and maintaining the site activation plans to deliver to contract and target, ensuring sites are progressed after identification to subject dosing without delay.
  • Accountable for the risk management and mitigation strategies within site activation to ensure timely delivery.
  • Working cross-functionally to ensure that the sites and countries optimize accelerated delivery of the project.
  • Ensure stringent oversight of project in terms of timely and quality delivery of key milestones and that the impact of missed deliverables is clearly and timely communicated to all key stakeholders. Accountable for management of sponsor expectations and ensuring compliance with ICON/sponsor KPls, ICON/sponsor SOPs, reporting norms, appropriate regulations and ICON's quality standards Represents Study Start Up at internal and sponsor calls.
  • Responsible for the study start up budget including resources, timelines, rates and margins. Responsible for keeping CO logs for SSU and ensuring PM is aware.
  • Responsible for staffing requests in line with study contractual and delivery needs. Solicits the engagement and the contribution of key study stakeholders to ensure optimum performance and cross collaboration.
  • Accountable for ensuring TMF relating to Study Start-up is inspection ready
  • Accountable for ensuring ICON reporting systems and tools are correctly used and updated in a timely manner Accountable for oversight and input into site activation CAPA process and works with site activation management to identify and roll out processes improvements
  • Creates and maintains an environment of "OwnIt" to become a trusted partner. This builds and enhances strong relationship with internal and external sponsors that result in a successful delivery of site activation by setting clear expectations, demonstrating ownership and accountability for own responsibilities and using "best practice" communication, such as clear and open dialogue. Invokes lessons learned and defines and uses other strategies/tools as required to assure optimized delivery and sponsor satisfaction.
  • Supports sales preparation materials and calls including bid defense for larger or complex studies where required.
  • Oversees day to day delivery of all aspects of site activation in the project/s assigned. Tasks may include, but are not limited to, master ICF development, supervision of translations, regulatory planning, contract/budget negotiations, site outreach.
  • Ensures that each project has a site activation plan and that the study is being conducted in accordance with that plan which meets or exceeds sponsor timelines and expectations and is in compliance with ICON/sponsor KPIs, ICON /sponsor 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 sponsor satisfaction
  • Ensure effective resource planning and SSU resource requesting within projects assigned
  • Effectively embrace and foster change with respect to process improvement initiatives across site activation.
  • Work closely with peers to ensure global consistency in the successful execution of site activation activities and services across the SSU function.
  • Ensure that study performance is objectively and systematically measured and reviewed on a regular basis and reports or presents status to relevant management Manage and escalate any significant variations to study budgets, identifies out of scope activities and ensures to input into change orders as required.
  • As a member of staff the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting sponsor needs.
  • Travel (approximately 20%) domestic and/or international. Other duties as assigned.

What you will need:

  • In depth proven experience within clinical research with experience in the clinical studies regulatory environment and leadership role.
  • Minimum 6 years' experience within clinical research with experience in the clinical studies regulatory environment, and experience in staff oversight/leadership role.
  • Cross-functional leadership and influencing skills demonstrating the following key competencies: sponsor focused individual who proactively seeks original solutions and takes ownership to ensure delivery exceeds expectations;
  • Critical thinker willing to question the way things are done to improve efficiency;
  • Good planner who demonstrates organizational ability, also under time pressure
  • Ability to make analytic and data focused decisions in a fast paced environment;
  • Team-focused individual who builds strong relationships and fosters a collaborative work environment Strong negotiator who effectively manages conflict to positive resolution; and strong communicator who adapts style to circumstances and favors an honest and open approach;
  • Flexible individual who is excited about the opportunities represented by change.
  • Ability to successfully manage, positively interact and liaise successfully with all levels of staff at ICON, vendors, and sponsors.
  • Due to the nature of this position it may be required for the employee to travel, including air travel.
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