Start Up Associate Project Manager
(Clinical Operations Manager – Regulatory)
Remote, Montreal, Quebec, Canada
Why settle for one thing when you can have everything?
Covance gives you the best two-for-one opportunity for career growth. Who doesn't want twice the perks? Working at Covance—one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!
As a Covance 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, Covance 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 Covance'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.
Covance'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.
Covance'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 Start Up Associate Project Manager 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:
- Creating ICFs including language and negotiation
- 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:
- Determining needs, request, and manage project start-up resources; adapting/requesting resources as applicable to ensure project deliverables are met
- Ensuring effective cross-functional teamwork among project team members including both internal and external ancillary services; resolve conflicts as needed
- 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
- 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:
- 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
- Responsible for appropriate issue escalation to QA Triage and/or appropriate stakeholder(s)
- Supporting audits (internal and external) and inspections, as needed and supporting the resolution of any findings.
- Bachelor's degree (life sciences preferred) or certification in a related allied health professions (i.e.. nursing, medical, laboratory technology) from an appropriately accredited institution. In lieu of the above requirement, candidates with four or more years of relevant Clinical Research experience in Pharma, CRO or healthcare setting experience will be considered.
- Five to Seven years of clinical research experience
- Experience negotiating and developing local language materials including local language Informed Consents and translations
- Solid experience negotiating IRB language and templates
- Experience interacting with IRB/IEC and Regulatory Authority for assigned protocols
- Demonstrated skills and competency in clinical project management task especially study start-up
- Expertise of core clinical systems, tools and metrics
- Local project coordination and/or project management experience especially study start is preferred.
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