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Associate Director, Clinical Operations Lead - Italy  

Company managed [?] Still accepting applications

Posted on : 28 May 2017

Project Description

Position Summary
Local oversight of assigned clinical trials to ensure GCP compliance,  patient safety, quality and timely study execution in accordance with prevailing laws, Good Clinical Practices, and company  Standards.



Responsible for the study execution at a site level to:
  • Ensure overall quality and compliance of local site management and monitoring conducted by external CRAs
    • Ensure appropriate oversight of monitoring
    • Proactively identify, manage, escalate,  resolve and mitigate  study issues at a site level
    • Maintain a thorough knowledge of disease area and protocols
    • Conduct training with CRO CRAs and study site staff as required
    • Drive local timelines in alignment with global plan
    • Identify potential study sites in collaboration with the study team, CRO and local Medical Affairs
    • Conduct feasibility assessment and make recommendations for site selection
    • Provide input into the study specific clinical monitoring plans
    • Conduct Sponsor Oversight Site Visits (SOSV) with assigned CRO CRAs as appropriate
    • During SOSV:
      • Ensure  execution of and adherence to monitoring plan
      • Ensure regulatory compliance & GCP adherence by monitors and site personnel
      • Ensure accurate and reconciled drug accountability at local level
      • Ensure appropriate Investigator Site File documentation filed for each study site assigned
    • Validate local CRO resources, as necessary, to support execution of the study
    • Demonstrate leadership in the resolution of site issues in order to maintain data quality and effective site management
    • Act as company point of contact  for the site: develop and maintain productive  relationships
    • Develop  and maintain site risk management indicator system to prioritize SOSV activities to minimize risk
    • Provide feedback to Internal and External Stakeholders as appropriate


  • Acts as Lead COL as assig
    • Liaison between COL and Study Team: act as the central point of contact for the COL team
    • Reviews SSV and makes recommendations to CPL and Medical Monitor as required
    • Standardize processes across the study: ensure efficiencies in the way the COL team performs SOSV activities
    • Track trends occurring within the study to proactively identify and resolve issues across regions
    •  Communicate findings at one site that may be prevalent in others to proactively remediate issues that arise
    • Track trends occurring within the study that may impact other studies and communicate to other LCOLs
    • Liaise with other LCOLs to standardize processes across multiple studies



 
Principal Responsibilities
Site Management Interface
  • Conducts SOSV as appropriate; likely to involve extensive travel
  • Acts as a company Point-of-Contact for the site; CRO CRA is the first PoC
  • Leads local Investigator relationship management

Global Study Management Interface (LCOL)
  • Serves as Point-of-Contact for CPL for assigned protocol
  • Drives local activities to meet study objectives/milestones through CRO
  • Supports preparation/participation of global/regional Investigator meeting as required
  • Produces, delivers and communicates various progress reports which identify and address study progress and quality issues

Review of Site Visit Reports 
  • Performs Site Visit Report review in preparation for SOSV
  • Supports CRA with issue escalation identified at SOSV

Protocol feasibility and Site Selection
  • Support country level protocol feasibility
  • Provide input into site assessment/qualification questionnaire (LCOL)
  • Provides local site recommendations in collaboration with CRO and local Medical Affairs

Study Oversight
  • Assess the competencies of disease and protocol knowledge of CRA.  Ensure retraining is performed, if necessary
  • Conduct SOSV to ensure quality and compliance
  • Identifying and escalating issues  to relevant study team members for resolution
  • Ongoing risk assessment and mitigation

Inspection Readiness, Compliance and Audit Responsiveness
  • Conduct SOSV to ensure quality and completeness of data for inspection readiness
  • Assist in local follow-up and resolution of internal audit and regulatory agency inspection issues in alignment with R&DQ

Local Affiliate Interactions
  • Regular updates to Medical Affairs on study status
  • Develop and maintain local country relationships

 

Qualifications
Work experience
  • At least  ten  years of clinical research experience in Biopharma or CRO
  • Extensive site management and monitoring experience across a range of disease areas
  • Demonstrated capability of effective CRA and site oversight
  • Solid knowledge of clinical development processes with strong emphasis on monitoring
  • Demonstrated project management skills  across multiple highly complex clinical  studies
  • Track record of establishing effective relationships with investigator sites
  • Ability to lead, troubleshoot and influence for quality and delivery
  • Experience of ultra rare disease clinical research is beneficial
  • Experience of managing multiple studies including extensive experience in the management and oversight of CROs is crucial
  • A track record of ensuring GCP compliance  and successful  risk management of complex clinical studies is expected
     



Major Skills and expertise required for the role
  • Clinical and  regulatory processes
  • GCP
  • Site management and monitoring
  • Organization and prioritization skills
  • Project and risk management
  • Effective communication skills
  • Presentation skills
  • Problem Solving
  • Negotiating
  • Drive for results
  • Influencing
  • Collaboration
  • Dealing with ambiguity
  • Timely decision making
  • Command skills
  • Networking and alliance building
  • Conflict resolution
  • Self-starter and self-motivated

 

Education
  • Minimum requirement:  Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development 
  • Advanced degree is desirable.

 

About Us: 
  • Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company  developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.  
  • As the global leader in complement inhibition, our company  is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.  
  • Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders 
  •  In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.