Clinical Project Manager

Title: Clinical Project Manager

Location: Remote United States; Remote Canada

Department: Project Management

Job Description:

Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest's headquarters are located in Markham Ontario, Canada with additional locations in: Bridgewater, New Jersey; Shanghai, China; Taipei, Taiwan; and multiple offices in Europe.

 

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

 

Quality is our backbone, customer-focus is our tradition, flexibility is our strength.that's us.that's Everest.

 

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a Project Manager for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA or Canada in accordance with our Work from Home policy.

 

The Project Manager position is accountable for effective and efficient project and portfolio delivery from project start up through closure, ensuring all functional, technical, and financial aspects of the project are being managed effectively and against client and Everest expectations. The project/portfolio management duties include, but are not limited to, establishing the project/portfolio management and tracking foundation for an assigned client, establishing the overall client and service delivery strategy for a given project or group of projects, defining project scope and cost estimate budgets, planning, directing, and controlling project activities, and managing resources and budgets, and project team performance of cross-functional teams engaged in clinical research and development activities. This position is also accountable for reporting project progress status to Everest internal management and its clients, and regular project billing, invoicing, and financial tracking/reporting activities. These activities may include, but are not limited to, managing projects with activities focused on clinical operations, data management, statistics, medical writing, clinical trial technologies (including Interactive Web Response Systems [IWRS]/Interactive Response Technology [IRT] and eDiary/electronic Patient Reported Outcome [ePRO]), administration of data monitoring and adjudication committees, and preparation of drug submissions to regulatory agencies.

 

When required, the incumbent may assist the organization in responding to and preparing for Request for Information (RFI) and Request for Proposals (RFP), analyzing the study protocol and project parameters, and subsequently developing cost estimate budgets and performing contract administration activities working with senior leaders in Business Operations.

 

When required, the incumbent may also lead project management capability development activities, including the development or enhancement of Standard Operating Procedures (SOPs), project management software, project delivery and control process improvement, and training initiatives.

 

Key Job Accountabilities:

 

1. 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.


2. 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 


3. 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.

 

 

1. Support general operational and capability building activities for the Project Management department. These include, but are not limited to, the following:


2. 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.

Qualifications and Experience

 

1. Bachelor of Science or Master of Science in life sciences or health related field.


2. Minimum of 8 years of clinical research experience within a pharmaceutical, biotechnology, or contract research organization setting.


3. Fluency in Mandarin Chinese is required.


4. Oncology experience is preferred.


5. Experienced as a clinical trial monitor; initiating, monitoring, and closing out clinical trials will be desirable for Clinical Operations support tasks.


6. 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.


7. Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.


8. 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.


9. Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets.


10. Excellent interpersonal, oral, and written communication skills. Demonstrated strong negotiation and presentation skills.


11. Strong ability in problem-solving, including conflict resolution.

 

 

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com

 

We thank all interested applicants, however, only those selected for an interview will be contacted.

 

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.

 

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