Everest Clinical Research · 2 hours ago
Senior Clinical Project Manager
Bridgewater, NJ
Full-time
Hybrid
Senior Level, Lead/Staff
$120K/yr - $140K/yr
8+ years expEverest Clinical Research is a full-service contract research organization providing expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries. They are seeking a Senior Clinical Project Manager to oversee project and portfolio delivery, ensuring effective management of all functional, technical, and financial aspects of clinical projects from start to closure.
Pharmaceutical
Responsibilities
Drive effective and efficient management of projects with activities focused on one or more of Everest service areas/functional groups: clinical operations, data management, statistics, medical writing, clinical trial technologies (IWRS/IRT and eDiary/ePRO), administration of data monitoring and adjudication committees, and preparation of submissions to regulatory agencies
With the guidance of project leadership, ensure successful project team mobilization and communication throughout a project’s lifespan to ensure and proactively track project milestones, deliverables, and overall success. This includes, but is not limited to, the following:
Integrate information to develop project budgets for each in-scope service and develop and maintain cross-functional project work plans, including identification of resource requirements and utilization, and deliverable timelines
Prepare for and facilitate project kick-off meetings (internal and external, as applicable), ensuring dissemination of key project assumptions and information to relevant stakeholders
Implement project management tools required to ensure accurate tracking and transparency around project progress, expectations, and stakeholders. This may include project communication plans, risk mitigation strategies, statistics and programming tracking sheets, and etc
Lead all project management aspects of assigned Phase I to IV clinical trials and in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements. This includes, but is not limited to, the following:
Schedule and conduct project meetings (internal and external), communicate assignments, priorities, and expectations to project team members (across functional groups), and track completion of project deliverables to ensure quality and timeliness of all project-related tasks. This includes preparation of, with the support of key functional stakeholders, meeting agendas and minutes. In some cases, meeting minutes may be delegated to an Associate Project Manager or designee. This also includes scheduling and tracking of core project-specific training (e.g., protocol training)
Is expected to be the primary point-of-contact for clinical trial Sponsors to ensure the timely initiation of any Sponsor-requests that pertain to active clinical projects
Coordinate activities across functional project teams. Manage the planning, implementation, conduct, and reporting of assigned projects within the established timelines and budgets, and with the quality required by Everest and general industry regulatory standards. Coordinate activities between Everest and trial Sponsors and with various supporting groups or third party vendors (e.g., central laboratory and other specialty laboratories) to ensure that all contractual obligations are met and that any interdependent activities are coordinated effectively and timelines planned for accordingly (e.g., third party vendor data transfers are planned for appropriately in the biostatistics and programming delivery timelines)
Proactively track and manage project tasks against timelines and hours spent/budgets. Prepare project status and progress reports, maintaining accurate and current details for communication to internal and potentially external stakeholders. Alert management when there are risks of having major deviations
Proactively track and manage the financial status against work order budgets, hours spent, and tasks performed; reconcile expenses across sub-streams of activities (e.g., project attrition reports). This includes monitoring to readily identify out-of-scope tasks and potential need for Change Orders, under the guidance of management/project leaders
Review and report on overall client portfolio performance (i.e., project delivery, quality, financial performance) and work with senior Project Management leaders to identify areas of opportunities and challenges to define continuous improvement plans
Generate new sales leads by developing trust-based relationships with client counterparts, with the goal of winning repeat and new business based on client relationships established. Identify opportunities to offer additional Everest services to grow an existing client account
Function as leading facilitator of problem solving and conflict resolution, working with functional leaders to drive strategic and effective decisions and plans
Communicate project action items and key decisions through timely minutes and follow up actions
Support general operational and capability building activities for the Project Management department. These include, but are not limited to, the following:
Assist in the development and/or revision of training materials, SOPs, technology enablement, and creation of templates and work instructions to develop standardization and streamlined approaches within the Project Management functional group
Manage and support the establishment and maintenance of project information repositories to support Everest business analytics
Work with Business Operations leaders to help lead assigned Business Development initiatives, including, but not limited to, the following:
Organize and coordinate responses to and preparation for RFI and RFP across different functional groups, which includes tracking and supporting the completion of:
Cost estimates by engaging respective functional group leaders and Business Development Team
Proposal Development and writing, through the engagement of respective functional group leaders and compilation of key information and project assumptions to ensure quality and accuracy of proposal content
Support bid defense preparation, including materials development (e.g., presentation slides)
Support contract development, including Service Work Orders, Change Orders, and any other project-specific contracts
Qualification
Required
Bachelor of Science or Master of Science in life sciences or health related field
Minimum of 8 years of clinical research experience within a pharmaceutical, biotechnology, or contract research organization setting
Fluency in Mandarin Chinese is required
Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, subject randomization and drug supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing
Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations
Ability to define scopes and estimate budgets and plan and manage projects, including resource requirements and utilization, hours spent versus budgets, key deliverables, and timelines
Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets
Excellent interpersonal, oral, and written communication skills
Demonstrated strong negotiation and presentation skills
Strong ability in problem-solving, including conflict resolution
Preferred
Oncology experience is preferred
Experienced as a clinical trial monitor; initiating, monitoring, and closing out clinical trials will be desirable for Clinical Operations support tasks
Company
Everest Clinical Research
Everest Clinical Research is a firm which conducts clinical research by contract for firms across the globe in fields
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$0.1MKey Investors
FedDev
2020-12-07Acquired
2019-08-18Grant· $0.1M
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