Senior Project Manager, Study Start Up (Remote) West Coast/Midwest Based

Company: Labcorp
Location: San Jose
Posted on: October 12, 2021

Job Description:

Job Overview:

Job duties 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 level. 

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. 

GENERAL

? 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 management

? Proactively engaging 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.

FINANCE MANAGEMENT

? Ensure 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 systems.

? Implement and follow pre-approved procedures for write off or budget overages.

RESOURCE MANAGEMENT

? 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 services.

? 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,

? Schedule 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.

? Provide performance feedback of team members to respective line managers and project management team.

JOB SPECIFICS

? 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 local requirements.

? 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 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.

COVANCE LEADERSHIP OVERSIGHT/QUALITY ASSURANCE

? Prepare 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).

?Support audits (internal and external) and inspections as needed. Support resolution ofany findings.

OTHER

?Support RFP development and attend at Bid Defense Meetings, if required

?Perform other duties as assigned by management

Education/Qualifications:

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.

? 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 development.

? Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.

? Broad knowledge of drug development process and client needs.

Preferred:

? 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.

? Working knowledge of Covance SOPs.

Experience:

Minimum Required:

? 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 Start-up.

? Experience in managing global projects with moderate financial value.

? Demonstrated ability to handle multiple competing priorities.

? Ability to utilize resources effectively on moderate scope projects.

? Financial awareness and ability to actively manage financial tracking systems including moderate projects

? 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 staff.

? Excellent communication, planning and organizational skills.

? Ability to work independently.

? Ability to negotiate and liaise with clients in a professional manner.

? Ability to present to staff at all levels.

? Good computer skills with good working knowledge of a range of computer packages.

Keywords: Labcorp, San Jose , Senior Project Manager, Study Start Up (Remote) West Coast/Midwest Based, Other , San Jose, California