Senior Manager, Site Engagement – Sponsor Dedicated

ManagerManagerFull TimeRemoteSeniorTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

Arizona + 2 moreAll locations: Arizona, California, Colorado

Posted

7 days ago

Salary

Not specified

Seniority

Senior

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

• 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

Job Requirements

  • Substantial (8+ years) experience in clinical operations in a CRO, pharma or biotech company including site management/oversight, and site-level clinical study conduct
  • 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)
  • 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
  • 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
  • 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

Benefits

  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off

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