Manager Site Engagement

Manager, Site Engagement - Mexico

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

We are seeking a Senior Clinical Site Lead to join a dynamic team working within the client environment.

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

JOB SPECIFIC COMPETENCIES & SKILLS

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

Education Requirements

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

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

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

Benefits may vary depending on role and location.

Visit our careers site to about the benefits ICON offers.

Inclusion and Accessibility

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.