Centralized Start-up Lead
Posted on: January 23, 2023
Centralized Start-Up Lead
This role can be home based within the US or Canada.
Essential Job Duties:
- Primarily oversees and manages amendment phase of domestic
and/or international clinical trials. Where required, may also take
on start-up tasks under the direction of a Project Manager,
- Responsibilities include project managing defined study
activities within timelines, scope, quality and budget, ensuring
that client's expectations are met.
- Lead the team through the amendment phase of a study.
- Responsibilities may also include activating sites in active
- Serve as primary client contact with autonomy to interact
directly with the client on a broad range of contract amendment
issues and decisions .
- Monitor and control project schedule. Proactively engage in
both quality assurance and risk management activities to ensure
project deliverables are met.
- Develop an amendment submission and approval strategy in
conjunction with the Project Lead, other functional groups and the
client to ensure amendment deliverables are completed within agreed
project timelines and in accordance with client's
- Proactively manage amendment progress, expectations and
- Understand client expectations for deliverables/milestones, and
liaise with applicable functional teams in creation and
modification of site activation timelines throughout the lifecycle
of the project.
- Oversee preparation of amendment submission including but not
limited to ICF updates/review/approval and other necessary
- Oversee ethics and regulatory bodies submission and approval
status. Coordinate addressing queries ensuring required timelines
- Contribute to a Start-Up Plan if required, overseeing
Investigator Package compilation, green light approval and
contributing to a cross functional team ensuring that sites achieve
Ready to Enroll status on time.
- Review and provide input to core study documents, as
- Present at external and internal meetings including, but not
limited to: project core team and client meetings.
- Responsible for appropriate issue escalation to QA Triage
and/or appropriate stakeholder(s).
- Support audits (internal and external) and inspections, as
needed. Support resolution of any findings. FINANCE MANAGEMENT
- Ensure that work is performed within budget. Interpret billing
guidelines for the functional area/region and schedule training for
start-up team accordingly.
- Proactively identify risk of over-spend and track project
progress against financial milestones using applicable financial
- Implement and follow pre-approved procedures for write off or
budget overages. RESOURCE MANAGEMENT
- Determine needs, request, and independently manage project
start-up resources. Adapt/request resources as applicable to ensure
project deliverables are met.
- Ensure effective cross-functional teamwork among project team
members including both internal and external ancillary services.
- Identify and escalate non-compliance related to maintaining
professional standards, following processes and SOPs to respective
line managers and/or QA.
- Provide performance feedback of team members to respective line
managers and project management team. Minimum Experience Required:
- Four (4) or more years of drug development and clinical
research experience (pharmaceutical, biotech or CRO), including
demonstrated skills and competency in study start-up and/or
- Preferably local project coordination and/or project management
- Undertaken similar activities for > 6 months
- Direct Sponsor contact Preferred
- Undertaken similar activities in > 1 country for more than 6
- Experience in oversight of start-up activities
- Experience outside of region Education Required:
- University/college degree (life science preferred) or
certification in a related allied health profession (i.e. nursing,
medical or laboratory technology) from an appropriately accredited
institution. Labcorp is proud to be an Equal Opportunity
As an EOE/AA employer, Labcorp strives for diversity and inclusion
in the workforce and does not tolerate harassment or discrimination
of any kind. We make employment decisions based on the needs of our
business and the qualifications of the individual and do not
discriminate based upon race, religion, color, national origin,
gender (including pregnancy or other medical conditions/needs),
family or parental status, marital, civil union or domestic
partnership status, sexual orientation, gender identity, gender
expression, personal appearance, age, veteran status, disability,
genetic information, or any other legally protected characteristic.
We encourage all to apply.
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Keywords: Labcorp, Burlington , Centralized Start-up Lead, Accounting, Auditing , Burlington, North Carolina
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