Senior Start-Up Specialist

Job Overview:

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

Education/Qualifications:

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.

Experience:

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.

Labcorp is proud to be an Equal Opportunity Employer:

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