To provide expertise in the development of Clinical Site budget and grants information for inclusion in pre-award Client Proposals and post-award Clinical Site Agreements (CSAs).
Study Grants Analyst-II will act as an Account Level Grants Analyst lead for key Enterprise & Biotech Accounts managing multiple grants plan delivery for a Sponsor.
Additional Responsibilities May Include
- Mentorship of Study Grant Analyst I roles
- Participation in training and support programs
- Fulfilling subject matter expert or process improvement roles within GST.
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 resolutionSupport & build departmental or functional training plans, content & deliveryGeneral Administration & Operations
Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and Parexel SOPsParticipate in, Parexel and department system / standards improvement activities or committees, task force groups as needed, including change managementEnsure agreed levels of productivity / billability are maintainedComplete 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 mannerEnsure implementation of process improvements in response to client and team feedback and quality auditsLook within and beyond CRS to encourage teamwork, quality and productivity efforts to the benefit of CRS and ParexelSkills
Strategic Thinking skills that support the ability to create a sense of urgency and take a proactive, solutions-based approachExcellent analytical and problem-solving skills, to define and resolve issues in a variety of complex situationsLeverage 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 ResearchProficient in Microsoft Excel, Power Point, and Word softwareAbility to become proficient with Parexel systemsAdvanced ability to successfully manage a full workload across multiple and varied projects / tasks with enthusiasm and prioritize workload with attention to detailOutstanding negotiation, influencing and organizational skillsDemonstrable experience of stakeholder / relationship management with a client focused approach to work.Able to understand the business implications of decisions and impact on customerAn ability to assess situations and make and carry through difficult decisionAbility to successfully work in a ('virtual') team environmentKnowledge 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 grantsEducation
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experienceSkills Required
safe harbor , Healthcare Compliance, Hipaa, Microsoft Excel, fcpa