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

The candidate will be expected to travel to sites on the West Coast of the US.

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

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