As a Sr. SSU Manager, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with a well-known global pharmaceutical company with a strong portfolio in cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation medicines.

You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you if you are looking for an environment where people feel they belong and are empowered to reach their full potential, perform at their best and make a valued contribution to saving lives.

What you will be doing:
• Manages start-up activities for assigned studies at the regional level including supporting site identification/site recruitment/site selection, central and local submissions, site contracts, essential document preparation, Investigational Product (IP) release, site... initiation visits (SIVs) readiness, and overall regional site activation readiness to ensure deliverables meet quality and regulatory requirements, project timelines, budget, and sponsor expectations.
• Ensures that clinical delivery project team members and any other cross -functional team members needed to support regional site activations understand responsibilities and performance standards. Reviews metrics and other information sources to monitor team and individual performance, providing feedback to individual and functional manager (FM) as appropriate.
• Communicates effectively with project team members to ensure alignment of study start-up strategy and risk mitigation. Selects appropriate communication platforms to convey information effectively and efficiently. May present at intra-/inter-departmental meetings.
• Ensures quality standards and applicable regulatory requirements are met, in accordance with the protocol, applicable guidelines and local regulations for IP release and site activations.
• Identifies and escalates potential risks with the regional start-up activities and deliverables, inclusive of proactive mitigation planning.

You are:
• Stroung SSU experience at least 5 years in global CRO/Pharm company.
• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
• Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
• Local/Regional EC submissions experience
• Excellent team building and interpersonal skills.

Why ICON?

At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.

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, 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 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 – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles
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