Manager, Site Engagement

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Establish and manage site relationships, including but not limited to: Act as liaison between the company and investigational sites, building investigator and site staff awareness on client compounds • Develop and implement a plan, in collaboration with global and local teams, to raise the profile of the company and its global clinical development projects with current and potential investigators • Independently perform activities associated with the evaluation of investigational sites to build company network • Proactively work with Medical/Patient/Industry Associations to build company network and to promote company clinical trials • Develop knowledge of site capabilities and past performance to assess their potential as participating sites in client clinical trials • Ensure regular communication with local organization to align interactions with KTLs and other relevant local/regional stakeholders • Oversee site-level study start-up, conduct, and close-out activities outsourced to CRO(s) for global programs across Therapeutic Areas • Support Site Agreement negotiations, including stand-alone and Master Site Agreements • Identify trends, issues and risks across sites, and work with external vendors and internal Trial Team to resolve/mitigate those • Collaborate with external vendors and internal Trial Team, to ensure that sites are activated in a timely manner and according to agreed timelines • Collaborate with external vendors and internal Trial Team, to ensure that sites deliver on expected recruitment targets, including identifying reasons for non-recruitment, and identification of non-performing sites that require actions • Ensure ICH/GCP/local regulatory requirements are observed • Provide documented sponsor site oversight at country level for outsourced trials in country under remit as required by regulation • Utilize site performance and quality data to optimize prioritization of oversight actions

🎯 Requirements

• Detailed understanding of all aspects of clinical protocol design and implementation, clinical site monitoring as well as overall global drug development • Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g. ICH GCP and applicable regional/local regulations) • Oncology and/or Neurology and/or Immunology TA experience desired • Substantial (8+ years) experience in clinical operations in a CRO, pharma or biotech company including site management/oversight, and site-level clinical study conduct • Strong communication skills (verbal, written and listening) in both native language and English • Aptitude to interpret and to integrate site performance data in prioritization of oversight activities • Understanding of applicable T&E Policy requirements • Role requires domestic and international travel up to 50% of time • Ability to work independently on assigned tasks or projects of increasing complexity • Capability to perform self-training incl. on therapeutic area, and synthesize the key take-away points for studies under remit • Normally receives no instruction on routine work and only general instruction on new assignments • Sound negotiation skills and adapting to a variety of parties • Record of vendor interactions • Sound critical thinking skills and ability to understand complex patient histories, medical terminology and specific therapeutic area treatment landscapes • Detail-oriented, organized and committed to quality and consistency • Results driven and capable of managing competing high-priority assignments • Proven track record of achieving deliverables within specified timelines • Ability to work in a dynamic environment with a high degree of flexibility • Ability to communicate effectively with Key Opinion Leaders, site staff, and internal team members • Experience and proven proficiency in CTMS and eTMF systems preferred

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways