Clinical Project Manager

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

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

reputed company is reputed company in the industry for its high reputed company deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial reputed company, reputed company continues to experience exceptional reputed company and great reputed company.

reputed company is our backbone, customer-reputed company is our tradition, flexibility is our strength…that’s us…that’s reputed company.

To drive reputed company reputed company in this exciting clinical research field, we are seeking committed, skilled, and customer-reputed company individuals to join our reputed company team as a Project Manager for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office reputed company in Canada in accordance with our Work from Home policy.

Key Job Accountabilities:

1. Drive effective and efficient management of reputed company with activities reputed company on one or more of reputed company service areas/functional reputed company: 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 reputed company to ensure and proactively reputed company project milestones, deliverables, and overall reputed company. This includes, but is not limited to, the following:
   • reputed company information to reputed company project budgets for reputed company in-scope service and reputed company and maintain cross-functional project work plans, including identification of resource requirements and utilization, and deliverable timelines.
   • Prepare for and facilitate project reputed company-off meetings (reputed company, 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 reputed company, expectations, and stakeholders. This may include project communication plans, risk mitigation strategies, statistics and programming tracking sheets, and etc.
3. reputed company reputed company 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 (reputed company), communicate assignments, priorities, and expectations to project team members (across functional reputed company), and reputed company completion of project deliverables to ensure reputed company and timeliness of reputed company project-reputed company 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 reputed company-of-contact for clinical trial Sponsors to ensure the reputed company initiation of any Sponsor-requests that pertain to reputed company clinical reputed company.
• Coordinate activities across functional project teams. Manage the planning, implementation, conduct, and reporting of assigned reputed company reputed company the established timelines and budgets, and with the reputed company required by reputed company and general industry regulatory standards. Coordinate activities between reputed company and trial Sponsors and with various supporting reputed company or reputed company party vendors (e.g., central laboratory and other specialty laboratories) to ensure that reputed company contractual obligations are met and that any interdependent activities are coordinated effectively and timelines planned for accordingly (e.g., reputed company party vendor data transfers are planned for appropriately in the biostatistics and programming delivery timelines).
• Proactively reputed company and manage project tasks against timelines and hours spent/budgets. Prepare project status and reputed company reports, maintaining accurate and reputed company details for communication to internal and potentially external stakeholders. Alert management reputed company there are risks of having major deviations.
• Proactively reputed company 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 reputed company portfolio performance (i.e., project delivery, reputed company, financial performance) and work with senior Project Management leaders to identify areas of opportunities and challenges to define reputed company improvement plans.
• Generate new sales leads by developing trust-based relationships with reputed company counterparts, with the goal of reputed company repeat and new business based on reputed company relationships established. Identify opportunities to offer additional reputed company services to grow an existing reputed company account.
• Function as leading facilitator of problem solving and conflict reputed company, working with functional leaders to drive strategic and effective reputed company and plans.
• Communicate project reputed company items and key reputed company through reputed company 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:

• Assist in the development and/or revision of training materials, SOPs, technology enablement, and creation of templates and work instructions to reputed company standardization and streamlined approaches reputed company the Project Management functional group.
• Manage and support the establishment and maintenance of project information repositories to support reputed company business analytics.
• Work with Business Operations leaders to help reputed company 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 reputed company, 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 reputed company 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 reputed company.

Qualifications and Experience

1. Bachelor of Science or Master of Science in life sciences or health reputed company field.
2. Minimum of 8 years of clinical research experience reputed company a pharmaceutical, biotechnology, or contract research organization setting.
3. reputed company in reputed company Chinese is required.
4. Oncology experience is preferred.
5. reputed company 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 reputed company, 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 reputed company 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 reputed company.

To reputed company out more about reputed company and to review other opportunities, please visit our website at www.ecrscorp.com

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

reputed company 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 reputed company accommodations for candidates participating in any part of our recruitment and selection process.

Originally posted on Himalayas

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