US, West Coast, Mexico, Manager, Site Engagement

Icon • Long Beach, CA

6d

About The Position

US, West Coast, Manager, Site Engagement ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are seeking a Senior Clinical Site Lead to join a dynamic team working within the client environment. The candidate may reside in California (might be open to other West Coast states) or Mexico and must be bilingual in English and Spanish. The candidate will be expected to travel to sites on the West Coast of the US and Mexico. What you will be doing: Site Oversight & Delivery Activities 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, including but not limited to: 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 You are: 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

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)
• 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
• Ensuring compliance with 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
• Requires graduate background (Medical or Life Sciences degree) in a clinical research related discipline or equivalent

Nice To Haves

• Oncology and/or Neurology and/or Immunology TA experience desired
• Experience and proven proficiency in CTMS and eTMF systems preferred

Responsibilities

• 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, including but not limited to:
• 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

Benefits

• In addition to your competitive salary, ICON offers a range of additional benefits.
• Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees