Assoc Proj Manager, Start-Up

Labcorp gives you the best two-for-one opportunity for career growth. Who doesn’t want twice the perks? Working at Labcorp—one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!

As a Labcorp employee dedicated to an FSP project, you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance, Labcorp has an FSP opportunity to match your area of expertise.

You will enjoy the best of both worlds—all the benefits that come along with Labcorp’s Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor and this also comes with the benefit of bringing your strong therapeutic experience to allow your expertise to shine through.

Labcorp’s FSP model is flexible and scalable. Our teams are collaborative and proactive – a great place for you to continue honing your therapeutic skills and growing and excelling in new and exciting research.

Labcorp’s reach is global – extending to 60 countries making us one of the largest FSP CROs. No matter where you are located on the globe, we have an FSP opportunity for you.

We are seeking a Associate Project Manager, Start Up to Lead start-up team during study start-up phase liaising directly with Lead Start Up Project Manager or Project Lead, core team members and the client, as applicable.

In this role, the selected candidate will serve as client’s contact for start-up and maintenance processes and oversight; be responsible for establishing a strong working relationship with client’s project teams; monitor and control start up project schedule and scope; proactively engage in both quality assurance and risk management activities to ensure project deliverables are met; and initiate improvements to enhance the efficiency and the quality of the start-up work performed on assigned projects.

Additional responsibilities include:

• Developing 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
• Creating/reviewing required project start-up plans; distributing, implementing and monitoring compliance to project plans and revise as necessary; and reviewing Client vs CRO responsibilities as related to start-up
• Understanding client expectations for deliverables/milestones, and liaising with applicable functional teams in creation and modification of site activation timelines throughout the lifecycle of the project
• Reviewing and providing input to core study documents, as applicable
• Proactively managing site activation and maintenance progress, expectations and deliverables to a Lead Start Up Project Manager or the Project Lead/client, as applicable
• Presenting at external and internal meetings including, but not limited to: project core team and client meetings, Chapter Meetings, Kick Off Meetings
• Distributing start-up and maintenance related documents to local start-up staff and oversee the customization to local requirements
• Overseeing ethics/regulatory bodies submission, approval status and coordinating addressing queries ensuring required timelines are met
• Ensuring preparation and distribution of core and country specific contract and budget templates to applicable project team members
• Overseeing Investigator Package compilation and green light approval regionally and/or globally; proactively identifying and escalating any risks to meeting deliverables; and proposing effective mitigation plan, as applicable
• Monitoring Green Light (GL) approval regionally to ensure deliverables are met; and proactively identifying and escalate any risks to meeting deliverables
• Oversee maintenance activities through the lifecycle of the project
• Support RFP development and attend at Bid Defense Meetings, if required and performing other duties as assigned by management
• Resource Management duties include:

o Determining needs, request, and manage project start-up resources; adapting/requesting resources as applicable to ensure project deliverables are met

o Ensuring effective cross-functional teamwork among project team members including both internal and external ancillary services; resolve conflicts as needed

o For all Start-up staff, identifying and escalating non-compliance related to maintaining professional standards, following processes and SOPs to respective line managers and/or QA

o Scheduling and conducting start-up related trainings to project teams (both internal and external), as applicable; ensuring that local staff has access and are trained on applicable systems; providing performance feedback of team members to respective line managers and project management team

• Quality Assurance duties include:

o Preparing and presenting 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 Director

o Responsible for appropriate issue escalation to QA Triage and/or appropriate stakeholder(s)

o Supporting audits (internal and external) and inspections, as needed and supporting the resolution of any findings.

Requirements Include:

• Bachelor’s degree (life sciences preferred) from an appropriately accredited institution.
• 5-7 years of clinical research experience

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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