Clinical Project Manager (Animal Health)
临床项目经理 （动物健康）- - 美国临床公司是为全球动物卫生行业提供服务的一组动物卫生合同研究组织的一部分。我们正在积极寻找一个北美医疗项目经理加入我们的不断扩大的实地临床试验团队。这个职位提供了远程工作的灵活性，偶尔需要办公室访问。这一职位为动物保健行业的专业增长和发展带来了一个令人兴奋的机会。主要的工作目的 协调实地临床试验 (FCT) 过程和资源，包括数据管理，监测器，QA 支持，法律，金融团队，研究调查人员，实验室和快递员。与赞助商进行沟通并确保 FCT 的质量及公司 SOP,政策，做法以及赞助人的期望按时完成。工作特定职责和责任 ·在所有阶段协调 FCT （例如可行性评估，报价，设置，现场阶段，闭合，报告和研究主文件编译）,与负责团队成员联系，对集团内部提供的服务提供相关信息，并管理外部合作伙伴和供应商之间的关系。·确保项目完成其生命周期，产品符合达成的时间表，质量和成本。·通过定期项目审查会议的实施和协调向管理层和赞助商报告项目状况，包括预算和时间表。·积极确定可能危及项目的风险，例如技术可行性，资源可用性，及时执行，预算限制等。·开发和维护项目管理工具，包括但不限于 Gantt 图表，项目预算，预测等。·与不同部门，合作伙伴公司和外部合作伙伴进行联系和协调，以确保在计划时间内可提供必要资源来执行所需的功能，以实现项目成果。·作为主办方的主要项目接触者，以确保沟通和报告日程得到遵守。·开发包括研究具体材料和 GCP 材料在内的现场培训资料。·指导并培养其他团队成员关于 FCT 管理。·内部外推广组织的能力和价值观。·履行 GCP 和非 GCP 研究中的监督责任。·酌情为学习水平风险评估做出贡献。
查看英文原文
Clinical Project Manager (Animal Health) - United States of America
Clinaxelis part of a group of Animal Health Contract Research Organizations servicing the global animal health industry.
We're actively seeking aNorth Americanbased Clinical Project Manager to join our expanding field clinical trials team. This role provides the flexibility to work remotely, with occasional office visits required.
This position presents an exciting opportunity for professional growth and development in the Animal Health industry.
Primary Job Purpose
Coordinate Field Clinical Trials (FCT) processes and resources, including data management, Monitors, QA support, legal, finance teams, study Investigators, laboratories, and couriers.
Manage communication with the Sponsor and ensure FCT's quality and timely completion per company SOPs, policies, practices, and Sponsor's expectations.
Job Specific Duties and Responsibilities
- Coordinate FCT across all their phases (e.g., feasibility assessment, quotation, set up, live phase, close-out, reporting, and study master file compilation), liaise with the responsible team members for the services performed within the group, and manage the relationship with external partners and vendors.
- Ensure projects complete their life cycle and deliverables meet the agreed timelines, quality, and cost.
- Report to management and Sponsors on the status of projects, including budgets and timelines, through the implementation and coordination of regular project review meetings.
- Proactively identify risks that might jeopardize projects, e.g., technical feasibility, availability of resources, timely execution, budget constraints, etc.
- Develop and maintain project management tools, including but not limited to Gantt charts, project budgets, forecasts, etc.
- Liaise and coordinate with different departments, partner companies, and external partners to ensure that necessary resources are available to perform the required function at the planned time to achieve the project outcomes.
- Serve as primary project contact with Sponsors to ensure that communication and reporting schedules are followed.
- Develop site training materials including study specific materials and GCP materials.
- Mentor and train fellow team members on FCT management.
- Promote the organization's capabilities and values internally and externally.
- Fulfil Monitor responsibilities within GCP and non-GCP studies, where applicable.
- Contributing to study-level risk assessments.
- Identifying and resolving issues at a global level.
- Leading global study-level documentation and required tool and systems set-up.
Qualification, Training and Experience Requirements
- DVM or related Life Sciences degree, accompanied by a minimum of five years of experience in Field Clinical Trials (FCT) and Project Management.
- Ideal candidates should demonstrate industry awareness, including expertise in the pharmaceutical sector, familiarity with FDA/CVM, USDA/CVB, EMA, VICH Guidelines, Clinical Field Trials, and data quality requirements.
- Animal Health clinical experience highly preferred
Important Note to Applicants
This is aremote positionwith potential for regular travel.
Please be aware that Internet Explorer is not compatible with BambooHire.
The Company complies with local and international data protection and privacy legislation. This includes transparency in the processing of personal information processed about job applicants during the recruitment process. By applying for this position, applicants agree to the processing of their personal data in accordance with our recruitment procedure and Privacy Notice available from our website.
As part of the hiring process, candidates need to willingly take part in personality and behaviour assessments to determine a good fit for the job role. These assessments assist with evaluation of candidates in a fair and thorough manner. All information gathered are kept private and only used to assess suitability for the job role. The Company may perform criminal and/or other relevant checks (as is relevant to the position) on all applicants applying for this position.
Location
Fort Collins, CO (Remote)
Department
Clinaxel United States of America
Employment Type
Permanent, Full-Time Employee
Minimum Experience
Experienced
Compensation
$100,000 - $150,000
Salary: $100,000-$150,000Originally posted on Himalayas