Manager, Site Engagement Liaison

IRE•Long Beach, CA

About The Position

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

Requirements

MUST reside in California (might be open to other West Coast states)
Bilingual/Spanish Speaking and ok with travelling to sites in Mexico
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

Establish and manage site relationships
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