The jobholder, an SME for local/regional regulations, works with multiple vendors, drives and coordinates activities across a range of stakeholders in support of site start up delivery.
This role liaises with Covance Regulatory to ensure compliance, coordinates best practice solutions within region and coaches others in the more complex areas of SU. The Senior SU Specialist proactively anticipates and mitigates issues that could delay start up across a range of sites.
Is the escalation point for negotiations with SUPM/SUCM’s on behalf of less senior colleagues.
Provide expertise for local regulations, ICH/GCP and relevant study and Sponsor requirements.
When delegated by Start-up Country Manager (SUCM), oversee and ensure quality data and audit readiness.
Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required.
Ensure efficient in country execution and local improvements aligned with global requirements.
Review and approve projections and timelines to study teams, ensuring that they accurately represent the country’s performance and suggests mitigation actions in agreement with SUCM.
Develop project specific plans for the Site Activation component of assigned studies
When appropriate, take a lead in team meetings to resolve issues and progress the trial
Review and approve Country and Site Specific patient informed consents for compliance to local requirements and protocol with agreement by SUCM.
Proactively resolve informed consent and contractual language issues plus other significant barriers to study execution with study sites
Oversee start up activities (possibly across a range of studies) to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual
Liaise with Covance regulatory regarding document submission requirements
Ensure appropriate systems are updated accurately and compliantly, with site information and study dates (projected and actual) ensuring others follow established processes
Coach other start-up team members
May take country start up lead role for larger/more complex projects
May have line management responsibilities for a small number of staff, including performance management, career development, regular one to one’s salary and promo recommendations
Perform other duties as assigned by management.
Level of education preferred (if required or experience level which may be substituted for level of education).
Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).
University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 4 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 5 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered.
More than 4 years of experience in clinical development or regulatory process.
In depth experience of applying strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines. Expert knowledge of investigator start-up documents; previous interaction with operational project teams and investigative sites.
In depth experience of issue escalation and resolution.
Credible role model in effective communication and problem solving.
Proven strengths managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external to the organization.
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