Project Manager/Associate Project Manager - Study Start Up (Remote) West Coast/Midwest Based
Location: Los Angeles
Posted on: October 12, 2021
note: This is a remote position but we are currently heavily
targeting candidates to work in the Pacific and Mountain Time
Zones, located on the West Coast or in the Midwest. We are
open to PMs and Associate PMs of all skill level to join our
start-up team during study start-up phase liaising directly with
Lead SUPM or Project Lead, core team members and the
as client’s contact for start-up and maintenance processes and
for establishing a strong working relationship with client’s
and control start up project schedule, budget, and
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.
that work is performed within the budget. Interpret billing
guidelines for the functional area/region and schedule training
for start up team accordingly.
identify risk of over-spend and track project progress against
financial milestones using applicable financial
and follow pre-approved procedures for write off or budget
needs, request and manage project start-up resources.
Adapt/request resources as applicable to ensure project
deliverables are met.
effective cross-functional teamwork among project team members
including both internal and external ancillary
conflicts as needed.
non-compliance related to maintaining professional standards,
following processes and SOPs to respective line managers and/or
and conduct start-up related trainings, as applicable to project
teams (both internal and external).
local staff has access and are trained on applicable
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
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
client expectations for deliverables/milestones and liaise with
applicable functional teams in creation and modification of site
activation timelines throughout the lifecycle of the
and provide input to core study documents, as
manage site activation and maintenance progress, expectations and
deliverables to a Lead SUPM or the Project Lead/client, as
at external and internal meetings including, but not limited to:
project core team and client meetings, Chapter Meetings, Kick Off
start-up and maintenance related documents to local start-up staff
and oversee the customization to local
ethics and regulatory bodies submissions and approval status.
Coordinate addressing queries ensuring required timelines are
preparation and distribution of core and country specific contract
and budget templates to applicable project team
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.
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.
LEADERSHIP OVERSIGHT/QUALITY ASSURANCE
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
for appropriate issue escalation to QA Triage and/or appropriate
audits (internal and external) and inspections, as needed. Support
resolution of any findings.
RFP development and attend at Bid Defense Meetings, if
other duties as assigned by management.
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
or other advanced degree.
knowledge of Covance and the overall structure of the
knowledge of Covance sales and business development strategies and
knowledge of Covance SOPs.
(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.
in managing projects in a virtual environment.
ability to handle multiple competing priorities and to utilize
awareness and ability to actively utilize financial tracking
ability to inspire effective teamwork and motivate staff within a
ability to lead by example and to encourage team members to seek
communication, planning and organizational skills.
to review/analyze and report relevant data and interpret protocols
and regulatory documents.
to work independently.
to negotiate and liaise with clients in a professional
to present to staff at all levels.
computer skills with an ability to understand, access and leverage
working knowledge of ICH GCP, US FDA regulations, regulations
applicable to local office, guidelines, and practices regarding
Good Clinical Practices.
knowledge of financial control procedures (i.e. costing systems,
knowledge of project management processes, especially concerning
knowledge of time and cost estimate development.
knowledge of drug development process and client needs.
Keywords: Labcorp, Los Angeles , Project Manager/Associate Project Manager - Study Start Up (Remote) West Coast/Midwest Based, Other , Los Angeles, California
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