Clinical Study Grant Analyst

Study Grant Analyst II

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

Site Contracts Administration & Operational Support

• Provide administrative and operational support for site contract negotiations and execution activities.
• Coordinate collection, processing, tracking, filing, and distribution of contracts, amendments, powers of attorney, confidentiality agreements, and related documentation.
• Manage signature workflows, including wet-ink and electronic signature processes.
• Coordinate translation requests, purchase orders, document shipment, and delivery activities.
• Maintain contract document repositories and ensure accurate record management within applicable systems.
• Track contract status and support reporting activities for internal and external stakeholders.
• Assist with contract-related systems, access requests, issue resolution, and workflow coordination.
• Support resource allocation tracking and project administration activities for Site Contracts teams.
• Assist in preparation of operational dashboards, KPIs, and performance metrics reporting.

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.
• Knowledge of clinical trial budgeting, investigator grants, and site contracting processes.
• 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 of experience in clinical research, study grants, site budgets, site contracts, study start-up, or clinical operations.
• Experience developing investigator grants and site budgets within CRO, pharmaceutical, biotechnology, or healthcare organizations.
• Experience managing contract administration activities and document workflows.
• Experience working with FMV benchmarking tools, budget databases, or grants management platforms.
• Proficiency in Microsoft Office Suite, particularly Excel.

Education:

• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experience