Project Manager, Start-up
Company: Labcorp Drug Development, Labcorp
Posted on: November 20, 2022
This position can be home based, anywhere within the United
States or Canada.
Essential Job Duties
Depending on the scope of the project and experience level, job
duties below, may be performed independently as a Lead SUPM or in
collaboration with a Lead SUPM as a Regional SUPM. Lead SUPM is
accountable for all job duties below. Regional SUPM supports Lead
SUPM by leading below job duties on a regional level.
- Lead start-up team during study start-up phase liaising
directly with Lead SUPM or Project Lead, core team members and the
- Serve as clients contact for start-up and maintenance processes
- Responsible for establishing a strong working relationship with
clients project teams.
- Monitor and control start up project schedule, budget, and
- Proactively engage in both quality assurance and risk
management activities to ensure project deliverables are met.
- Initiate improvements to enhance the efficiency and the quality
of the start-up work performed on assigned projects.
- Ensure that work is performed within the 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
- Determine needs, request and 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
- Resolve conflicts as needed.
- Escalate non-compliance related to maintaining professional
standards, following processes and SOPs to respective line managers
- Schedule and conduct start-up related trainings, as applicable
to project teams (both internal and external).
- Ensure local staff has access and are trained on applicable
- Provide performance feedback of team members to respective line
managers and project management team.
- In a lead role, develop a site activation and maintenance
strategy in conjunction with the Project Lead, other functional
groups and the client to ensure start-up and maintenance
deliverables are completed within agreed project timelines and in
accordance with clients expectations.
- Create or review required project start-up plans. Distribute,
implement and monitor compliance to project plans and revise as
necessary. Review Client vs CRO responsibilities related to
- 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.
- Review and provide input to core study documents, as
- Proactively manage site activation and maintenance progress,
expectations and deliverables to a Lead SUPM or the Project
Lead/client, as applicable.
- Present at external and internal meetings including, but not
limited to: project core team and client meetings, Chapter
Meetings, Kick Off Meetings.
- Distribute start-up and maintenance related documents to local
start-up staff and oversee the customization to local
- Oversee ethics and regulatory bodies submissions and approval
status. Coordinate addressing queries ensuring required timelines
- Ensure preparation and distribution of core and country
specific contract and budget templates to applicable project team
- Oversee Investigator Package compilation and green light
approval regionally and/or globally. Proactively identify and
escalate any risks to meting deliverables. Propose effective
mitigation plan, as applicable.
- Monitor Green Light (GL) approval and Site Ready to Enrol (RTE)
regionally to ensure deliverables are met. Proactively identify and
escalate any risks to meeting deliverables.
Labcorp Leadership Oversight/ Quality Assurance:
- Prepare and present as operational lead in internal Project
Review meetings, if in a lead role. Depending on the scope of
project, this job duty may be performed in collaboration with a
Lead SUPM, Start-up Senior Project Manager, and/or Start-up Project
- 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.
- Support RFP development and attend at Bid Defense Meetings, if
- Mentor Associate SUPMs
- Perform other duties as assigned by management.
Education/Qualifications/Certifications and Licenses
- 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. In lieu of the above requirement, candidates with five
(5) or more years of relevant clinical research experience in
pharmaceutical, CRO industries or experience in a health care
setting will be considered.
- Masters or other advanced degree.
- PMP certification.
- Working knowledge of Labcorp and the overall structure of the
- Basic knowledge of Labcorp sales and business development
strategies and procedures.
- Working knowledge of Labco SOPs.
- Five (5) or more years of drug development and clinical
research experience (pharmaceutical, biotech or CRO), preferably
including two (2) or more years project management responsibility /
leading clinical trials in Study Start-up.
- Experience in managing projects in a virtual environment.
- Demonstrated ability to handle multiple competing priorities
and to utilize resources effectively.
- Financial awareness and ability to actively utilize financial
- Demonstrated ability to inspire effective teamwork and motivate
staff within a matrix system.
- Demonstrated ability to lead by example and to encourage team
members to seek solutions independently.
- Excellent communication, planning and organizational
- Ability to review/analyze and report relevant data and
interpret protocols and regulatory documents.
- Ability to work independently.
- Ability to negotiate and liaise with clients in a professional
- Ability to present to staff at all levels.
- Strong computer skills with an ability to understand, access
and leverage technology alternatives.
- A working knowledge of ICH GCP, US FDA regulations, regulations
applicable to local office, guidelines, and practices regarding
Good Clinical Practices.
- Detailed knowledge of financial control procedures (i.e.
costing systems, time reporting).
- Working knowledge of project management processes, especially
concerning study start-up.
- Working knowledge of time and cost estimate development.
- Broad knowledge of drug development process and client
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, the organization will not discriminate in
its employment practices due to an applicant's race, age, color,
religion, sex, national origin, sexual orientation, gender
identity, disability or veteran status.
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Keywords: Labcorp Drug Development, Labcorp, Burlington , Project Manager, Start-up, Accounting, Auditing , Burlington, North Carolina
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