Associate Project Manager

2 weeks ago

Montreal, Quebec, Canada Labcorp Full time

_Essential Job Function:
_

  • Oversees and manages Clinical Pharmacology trials conducted at Labcorp Clinical research sites, external sites and biometric services projects under leadership direction; majority of projects are low to moderate in complexity yet full service trials of moderate financial value.
  • Primary client contact and responsible for the facilitation of communication, managing client expectations, and building business relationships.
  • Responsibilities typically include contributing to the development and management of the protocol, scope of the project, budget, timeline, and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks.
  • Responsible for managing the project team in a matrix environment with support as needed from a more senior CPS team member.
  • With mentorship from a more senior Project Manager or manager/supervisor as needed, acts a single point of contact for the client and leads the project team across Labcorp CRUs, and or external sites or biometrics while adhering to professional, SOP, Regulatory and ICH/GCP standards.
  • Assesses resource needs for projects based on scope of services to be provided.
  • Manages and communicates scope of the project according to proposal, budget, timeline throughout the lifecycle of the project. Works with project team on identification of work scope changes against the project timelines.
  • Creates and/or review required project plans. Implement and monitor progress against project plans and timelines and revise as necessary. If working on multiple studies for single client, may work under their manager or senior team member for assistance as to how to drive consistency across studies.
  • Organizes, chairs, and ensures accurate documentation in meeting minutes for project meetings with client and team, as applicable. Completes or delegates with oversight, the project Log (Action/Decision/Issue) items to ensure appropriate project team member delegation and resolution.
  • Performs overall management of the project timelines through use of MS Project ensuring that changes or updates are made and communicated in a timely manner. Renegotiate timelines with client and project team as necessary. With support from a more senior Project Manager or manager/supervisor as needed, implement risk mitigation strategies and oversight.
  • Develop understanding of clinical, biometrics and critical path activities.
  • Develop knowledge as to risk mitigation strategies, management and implementation to ensure project level deliverables are met. Escalate risks newly identified by the project team to stakeholders.
  • Responsible for the review and assessment of ongoing hour/budget utilization throughout the course of project to ensure that projects are meeting financial targets.
  • Collaborates with finance when project milestones or completion of contracted units of activity have been met to approve monthly invoicing and performs client follow up as appropriate.
  • Accountable for TMFs including TMF Index & Plan, audit readiness and delivery of TMF per agreed upon timelines, when contracted by client.
  • May oversee timely uploading of documents by the project team into the TMF for client held systems.
  • Accountable for directing the CTMS build, working with project team to ensure loading of information for site activation and timely entry of key milestones for site payment.
  • Accountable for developing Project Specific Training and ensuring project team members have read, reviewed and documented project related documents and plans.
  • Drives issue resolution at the project level with support from a more senior Project Manager or manager/supervisor as needed. Ensures proper escalation of potential CQI per Labcorp SOPs.
  • Contributes to audit responses from agencies and clients, as appropriate.
  • May assist in reporting of strategic client metrics.
  • Increase potential for repeat business by establishing a strong working relationship with client
project team striving for client satisfaction and operational excellence.

  • May track project metrics and report KPIs for strategic relationships.
  • May participate, contribute to a bid defense and other business development opportunities.
  • Perform other duties as assigned by management.

Site Management:

  • Responsible for the oversight of site start up activities.
  • Oversees the coordination of the study activation components of the project from an oversight level including Feasibility, Site Selection, Activation, Site Contracting, Label/supply, Regulatory Submission, Greenlight.
  • Assist in the design of feasibility assessments and patient recruitment campaigns.
  • Supervision of study setup with the clients regarding prestudy documentation for Investigator
packages.

  • Supervision of Investigator Package review and approval prior to drug shipment.
  • Supervision of Site Budgets and Statements of Agreements (SoA) documents that leads to an
executed site contr

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