研究奖学金分析师 II
Study Grant Analyst II
当我们的价值观一致时,我们能够实现无限可能。
在Parexel,我们都有相同的目标——改善全球健康。从临床试验到监管、咨询和市场准入,我们提供的每项临床开发解决方案都建立在一种特殊的理念之上——对我们所做工作的深刻信念。
无论我们在Parexel从事什么工作,都在为最终造福患者的疗法开发做出贡献。我们认真对待工作,以同理心去完成,并致力于带来改变。
关键职责:
编制资助估算
- 通过熟练使用Parexel要求使用的任何临床研究定价工具,及时准备准确且具有竞争力的临床研究资助(所有临床指征的I-IV期)。目前,该工具默认为Grant Plan。与其他提案团队成员协作,共同制定销售前业务提案的有竞争力的预算方案,同时遵守提案请求(RFP)和Parexel内部政策。
- 作为专业领域专家和负责人,负责已获批准项目的临床研究资助的创建、修订、升级和审批流程,与指定的站点合同负责人、研究项目负责人和项目总监合作,视情况而定。
- 为指定的站点合同负责人、研究项目负责人和项目总监准备额外的资助后临床研究分析,视情况而定。
- 在需要时参与策略会议和预算审查,以制定获胜主题,识别并评估竞争对手的基准,讨论客户的需求。
- 确保所有临床研究资助信息完全符合公平市场价格(FMV)原则和医生支付阳光法案。
- 熟悉医疗保健合规性和其他相关指南(如HIPAA、FCPA、安全港等)。
- 展示良好的知识共享能力,与团队分享经验教训和新场景。
- 提供并维护以客户为中心的资助分析,以衡量绩效并主动发现问题以便解决。
- 支持并建立部门或职能培训计划、内容和交付方式。
通用行政与运营
- 保持对适用的ICH指南、良好临床实践、监管机构要求和Parexel标准操作程序的了解,并确保合规
- 参与
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When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
Build Grant Estimate
- Timely preparation of accurate and competitive Clinical Study grants (Phases I – IV for all clinical indications) via proficient usage of any Clinical Study Pricing Tool that Parexel is required to use to support our Clients’ needs. The default, currently licensed tool in this regard is Grant Plan. Collaborate to prepare competitive budget concepts for Pre-sales business Proposals in conjunction with other members of the Proposal team while remaining compliant with the Request for Proposal (RFP) and Parexel internal policies.
- Subject Matter Expert and Lead on the creation, revision, escalation, and approval process of Clinical Study grants for awarded Projects with the assigned Site Contracts Leader and Study Project Leader and Project Director, as appropriate.
- Preparation of additional Post Award Clinical Study grant analyses for the assigned Site Contracts Leader and Study Project Leader and Project Director, as appropriate.
- Participation in strategy sessions and budget reviews when requested to develop win themes, identify, and assess competitor’s benchmarks and discuss client needs.
- Ensure that all Clinical Study grant information is performed in full compliance with Fair Market Value (FMV) principles and the Physician Payments Sunshine Act.
- Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.)
- Display good knowledge sharing capabilities, share lessons learned and new scenarios with the team.
- Deliver and maintain client-focused Grants analysis to measure performance and proactively identify issues for resolution
- Support & build departmental or functional training plans, content & delivery
General Administration & Operations
- Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and Parexel SOPs
- Participate in, Parexel and department system/standards improvement activities or committees, task force groups as needed, including change management
- Ensure agreed levels of productivity/billability are maintained
- Complete routine administrative tasks in a timely manner (e.g. timesheets, training, travel expense claims). Ensure compliance with travel and billability guidelines for department, region, or function, are met where appropriate. Travel as needed.
- Maintain a positive, results orientated work environment, building partnerships, and modeling teamwork, communicating to the team in an open, balanced and objective manner
- Ensure implementation of process improvements in response to client and team feedback and quality audits
- Look within and beyond CRS to encourage teamwork, quality and productivity efforts to the benefit of CRS and Parexel
Skills:
- Strategic Thinking skills that support the ability to create a sense of urgency and take a proactive, solutions-based approach
- Excellent analytical and problem-solving skills, to define and resolve issues in a variety of complex situations
- Leverage communication across boundaries and uses multiple communication mechanisms to convey information across functional lines and upward within Parexel.
- Client focused and demonstrated ability to create and maintain trust with the client through project and personal interactions; act as a trusted advisor and become involved in the client’s decision-making process.
- Ability to resolve issues independently and knows when to call on senior management for involvement in communicating to external & internal customers after assessing the organizational implications of the interaction and consultation with Senior Management.
- Familiarity with standard business and eClinical systems used in Clinical Research
- Proficient in Microsoft Excel, Power Point, and Word software
- Ability to become proficient with Parexel systems
- Advanced ability to successfully manage a full workload across multiple and varied projects/tasks with enthusiasm and prioritize workload with attention to detail
- Outstanding negotiation, influencing and organizational skills
- Demonstrable experience of stakeholder/relationship management with a client focused approach to work.
- Able to understand the business implications of decisions and impact on customer
- An ability to assess situations and make and carry through difficult decision
- Ability to successfully work in a (‘virtual’) team environment
Knowledge and Experience:
- 3 – 5 years’ work experience in clinical site budget development, (use of GrantPlan or Grant Manager) in a similar role within the managed care, pharmaceutical or bio-technology industries.
- Experience in the use of industry benchmarking databases and other tools utilized to ensure fair market value in the development of investigator grants
Education:
· Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experience
Originally posted on Himalayas