Sr Manager, Site Activation

Job Title: Snr Manager, Site Activation

Location: Across Europe

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role:

As Senior Manager Site Activation, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

Client Relationship:

• Support directly/indirectly sales preparation calls including bid-defense and study kick-off meetings where required. Ensure that the client and study teams understand key timelines, deliverables and milestones and that there is a clear strategic site activation delivery plan as well as risks/mitigation and communication plans to ensure each study is set up for successful project delivery and that both the interests of ICON and the client are robustly and equally defended.
• Manage contribution of key study stakeholders to ensure optimum performance and collaboration. Create and maintain the environment which allows successful delivery of site activation activities via clear and open dialogue and communication strategies/tools.
• Foster and develop key relationships with clients and internal customers and where needed participate on customer satisfaction initiatives.

Line/Operations Management

• Oversee day to day management of projects and personnel assigned to ensure each project has a strategic site activation delivery plan and that the study is being conducted in accordance with that plan and in an effective manner, meeting ICON/sponsor timelines and expectations and in adherence with ICON/client KPls, ICON/client SOPs, reporting norms, appropriate regulations and ICON's quality standards.
• Ensure effective resource planning and allocation within the portfolio of work assigned, including recruitment of high performing staff, line management of personnel within portfolio, ensuring and providing adequate training and training compliance, mentorship/coaching, career progression and succession planning. Agreeing and ensuring delivery of high quality performance and performance measurements.
• Ensure effective utilization and recovery of resources within portfolio. Ensure resources within portfolio operate in a professional. service-orientated and client focused manner.
• Identify, lead and input into process improvement initiatives across site activation activities. Ensure new initiatives are rolled-out and followed through.
• Coordinate effective cross-regional processes and procedures.
• Drive efficiencies and define strategies to overcome barriers to successful performance within portfolio and within the wider study start up group.
• Optimise operational efficiency through sharing & centralisation of information and promotion of best practice within the portfolio and the wider group. Effectively manage change within the portfolio and drive innovation and continuous improvement in all areas of responsibility.
• Proactively manage the studies and personnel assigned, quickly identifying barriers to success and defining strategies and mitigation plans to ensure prompt return to successful performance where required.
• Provide effective management support to the resources within your portfolio and continue to encourage a high performing culture within the teams. Carry out all relevant line management responsibilities including appraisals, goal setting and development plans.
• Communicate openly and effectively with direct line-manager on all critical issues, business growth opportunities and prepare/review status reports versus client deliverables taking appropriate actions.
• Work closely with peers to ensure global consistency, focus and development are achieved in the successful execution of site activation activities globally.
• Function as a key, senior level liaison for site activation and study start up with clients.

A Symbol of Excellence:

• Ensure that study and employee performance is objectively & systematically measured and reviewed on a regular basis.
• Comply with ICON's project governance system: keep senior management informed of project/resource/departmental status in relation to quality, cost and timelines.
• Ability and willingness to travel approx. 30% of the time (international and domestic).
• Other duties as assigned.

The Senior Manager Site Activation is accountable for the successful delivery of all site activation activities assigned.

This includes but is not limited to:
o The timely preparation and coordination of regulatory/ethic's submissions for all projects within the portfolio in line with project timelines and strategic delivery plan.
o Development and finalisation and review of Master and Country ·specific SIS/ICF and XML (EU).
o Ensuring receipt of Sponsor advice on the content of drug labels including review of translations including back-translations of drug labels where required.
o Ensuring all submission packages receive an independent quality review prior to submission.
o Co-ordination of timely negotiation of contract and budgets with sites. o Co-ordination of translations for documents required for submission.
o Ensuring timely and accurate data entry of all site activation activities in relevant trackers and tools.
o Ensuring timely follow up for queries raised by submissions authorities o Ensuring collection of critical docs required for IP release

• Accountable for the- development, monitoring, implementation and execution of the site activation del very plan in relation to contractual timelines including but not limited to PSV to SIV for all projects within the given portfolio. Manage risk up/down stream and define risk/mitigation, escalation and communicate plans and messages to effectively manage stakeholder expectation.
• Define and ensure observances of key controls/ checks to ensure projects are on target with potential obstacles/risks to success flagged in advance and addressed proactively and appropriately.
• Have a clear understanding of client objectives and ensure management of portfolio in line with client expectations, contractual obligations and operational delivery targets.
• Contribute/input into the development of effective and realistic strategic site activation delivery plan for each study within portfolio.
• Accountable for site activation activities in accordance with agreed budgeted hours. Manage and escalate any significant variations to study budgets, identify out of scope activities and input into change orders as required.
• Accountable for the provision of site activation metrics, tracking of key deliverables and metrics and re-base lining as required and ensuring internal/external clients are made aware of changes to site activation del very plan appropriately.
• Accountable for ensuring adequate and timely reporting iS provided to internal and external clients, that each project is audit-ready. That each site activation manager/ lead is ready to report site activation status of each project within portfolio to internal or external clients.
• Lead overall successful portfolio delivery, through your team. Drive execution of service, customer satisfaction, quality and efficiency for all site activation activities.

Benefits of Working in ICON:

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

At 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.

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, color, 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 through the form below.