What are the responsibilities and job description for the Manager, Site Engagement Liaison position at ICON plc?
We are seeking a Senior Clinical Site Lead to join a dynamic team working within the client environment.
The candidate MUST reside in California (might be open to other West Coast states), Bilingual/Spanish Speaking and ok with travelling to sites in 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
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