below primarily refer to a Lead SUPM role, but as needed Senior
Start-up Project Manager may hold a Regional SUPM position. Lead
SUPM is accountable for all job duties below. Regional SUPM
supports Lead SUPM by leading below job duties on a regional
Please note, due to client locations, we are targeting strong
candidates in the Pacific and Mountain Time Zones, located on the
West Coast or in the Midwest.
? Lead start-up and maintenance team during
study start-up and maintenance phase as a Lead SUPM liaising
directly with Project Lead, core team members and the client, as
applicable. Perform a regional SUPM role, as applicable.
? Serve as client’s contact for start-up and
maintenance processes and oversight. Responsible for establishing a
strong working relationship with client’s project teams.
? Monitor and control start up project
schedule, budget, and scope. Actively engaging applicable teams on
timelines, deliverables, TAQ reviews, billing and time
? Proactively engaging in both quality
assurance and risk management activities to ensure project
deliverables are met.
improvements to enhance the efficiency and the quality of the
start-up work performed on assigned projects.
awareness of and management of project 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
? Resolve conflicts as needed.
? For all
Start-up staff, identify and escalate non-compliance related to
maintaining professional standards, following processes and SOPs to
respective line managers and/or QA,
and conduct start-up related trainings, to project teams (both
internal and external), as applicable.
? Ensure local staff has access and are trained
on applicable systems.
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 client’s 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 start-up.
? 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 applicable.
? Proactively manage site activation and
maintenance progress, expectations and deliverables to the Project
Lead/client or the Lead SUPM , 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
? Oversee ethics and regulatory bodies
submission and approval status. Coordinate addressing queries
ensuring required timelines are met.
? Ensure preparation and distribution of core
and country specific contract and budget templates to applicable
project team members
? Oversee Investigator Package compilation and
amended IDLs, green light approval regionally and/or globally.
Proactively identify and escalate any risks to meeting
deliverables. Propose effective mitigation plan, as
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.
COVANCE LEADERSHIP OVERSIGHT/QUALITY
and present as operational lead in internal Project Review
meetings, if in a lead role. Depending on the size and scope of
project, this job duty may be performed in collaboration with aLead SUPM, Start-up Senior
ProjectManager,and/orStart-up Project Director.
?Responsible for appropriate issue escalation
to QA Triageand/or appropriatestakeholder(s).
audits (internal and external) and inspections as needed. Support
resolution ofany findings.
?Support RFP development and attend at Bid
Defense Meetings, if required
other duties as assigned by management
? 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.
? Working knowledge of financial control
procedures (e.g. costing systems, time reporting).
? Working knowledge of project management
processes, especially regarding study start-up.
? Working knowledge of time and cost estimate
? Working knowledge of ICH Guidelines and GCP
including international regulatory requirements for the conduct of
clinical development programs.
knowledge of drug development process and client needs.
? Masters or other advanced degree.
? PMP certification.
? Working knowledge of Covance and the overall
structure of the organization.
? Working knowledge of Covance sales and
business development strategies and procedures.
knowledge of Covance SOPs.
? Six (6) or more years of drug development
and clinical research experience (pharmaceutical, biotech or CRO),
preferably including three (3) or more years project management
responsibility / leading clinical trials in Study
? Experience in managing global projects with
moderate financial value.
? Demonstrated ability to handle multiple
? Ability to utilize resources effectively on
moderate scope projects.
? Financial awareness and ability to actively
manage financial tracking systems including moderate
? 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.
? Experience mentoring junior level
? Excellent communication, planning and
to work independently.
to negotiate and liaise with clients in a professional
? Ability to present to staff at all
computer skills with good working knowledge of a range of computer