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We are looking for a detail-oriented Clinical Research Proposal Specialist with prior experience in the life sciences industry, who possess excellent time management and communication skills to assist our Business Operations department in keeping up with the fast-paced environment that comes with the technology and life science industries.

Essential Duties and Responsibilities

• Utilize Excel and other provided tools to process reconciliations, change orders, BAU reports, budgets, and write proposals.
• Review RFPs (Request for Proposal); develop necessary budget assumptions from study protocols/synopses; and identify and resolve any questions that are needed to prepare a proposal.
• Participate in pre-RFP client/prospect meetings.
• Create competitive quotes based on the RFP
• Work with Business Operations, Medical and Operational personnel to develop effective proposals, including scopes of work, project assumptions, and budgets.
• Review and revise proposal content as needed to ensure a clear, compelling strategy to execute the trial is articulated.
• Creating and negotiating budgets.
• Present proposals to clients and prospects.
• Participate in client/prospect discussions and requests for information following delivery of proposal.
• Assist in the enhancement of tools and processes, as well as keeping up to date on industry norms and advances.
• Conducts qualitative and quantitative research to create customized and compelling business development documents focused on client solutions that highlight company differentiation, innovation, and operational strategy.
• Produces high quality, customer-specific deliverables.
• Ensures effective communication among internal stakeholders throughout the process so that the strategy drives the project and the final documents achieves its goals.
• Meets deadlines consistently by establishing priorities and target dates for document contributions, review, and approval by key stakeholders including executive leadership.

Qualifications

To perform this job successfully, an individual must have prior experience in performing each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience

• Minimum of a bachelor’s degree with a major in finance, accounting, business administration, business management, project or operations management, or another related field.
• Demonstrated proficiency with all Microsoft Office Tools.
• Must have advanced skills in Excel
• Excellent interpersonal and teamwork skills are imperative.
• Excellent time management.
• Must have strong customer service orientation and be a proactive and effective communicator.

Language Skills – Possess the ability to communicate and comprehend written and oral instructions. Able to effectively present information and respond to questions from colleagues and customers.

Reasoning Ability – Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Able to apply common sense solutions towards the execution of responsibilities.

Work Environment – This job is based out of our headquarters in Philadelphia, PA and is to be performed in the office.

Other – As provided by the Americans with Disabilities Act, the company is committed to discussing and providing reasonable accommodations to its employees to help them fulfill the essential functions of their jobs.

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

This is an equal employment opportunity and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status.

This is an entry level position.

Our ideal candidate is a professional to perform well in a team environment in the two most lucrative industries, healthcare and technology.

Responsibilities

• Update and keep records
• Research and qualify companies
• Provide troubleshooting assistance
• Stay up-to-date review project records
• Provide data to help the Business Operations
• Manage tracking tools and report on important information
• Liaise with accounts
• Be process oriented
• Competitor research
• Provide data to support your colleagues

Do your interests include?…

• Teamwork
• Working alongside high achieving colleagues
• Work that appeals to your numbers skills

Prevail InfoWorks is a great workplace for anyone, with unique advantages for those just starting out their career. We have had great success giving students and recent graduates opportunities with our company.

This job is based in our Philadelphia, PA headquarters. Job will be performed in office.

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

This is an equal employment opportunity and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status.

For information technology solutions provider for the clinical, logistical and financial management of medical research in the life sciences (Numoda Technologies, Inc. d/b/a Prevail Infoworks, Inc. – Philadelphia, PA): ensure that Prevail’s systems remain in compliance with the regulatory guidance that governs clinical trials; responsible for leading complex validation and testing activities to ensure Prevail’s computerized systems meet regulatory expectations and project requirements; provide subject matter expertise in validation strategy, test architecture, defect management and compliance oversight; support the QA team through mentorship, documentation review and risk-based testing approaches while working closely with technical and business teams to drive high-quality system releases; test and validate proprietary Prevail tools used in the production of Customer projects, according to Prevail Standard Operating Procedures (SOPs); serve as a subject matter expert in 21 CFR Part 11, ICH E6 (GCP), and validation best practices; lead and plan validation and testing efforts for complex or high-impact system releases; define and implement test strategies using risk-based and regulatory-driven approaches; review and approve validation artifacts, including test plans, traceability, and test evidence; perform advanced testing (workflow, boundary, integration, exploratory, and regression) and automation test scripts using Selenium Web driver 2.0 and Spec flow; lead defect triage, ensure proper prioritization, documentation, and resolution; support internal and external audit activities related to validation; mentor and train QA Analysts and review their work for compliance and documentation quality; recommend improvements to testing practices, validation procedures, and supporting tools; represent QA in cross-functional discussions, sprint ceremonies, and release readiness reviews; perform duties as directed by the Director of Quality Assurance Support and develop process improvement initiatives within the QA team and meet objectives as assigned.

Requirements:

1. Master of Science or foreign equivalent degree in Computer Science, Computer Applications, System Engineering or a related field.

2. 2 years of experience in the job offered or 2 years of experience as a Quality Assurance Analyst. The required experience must include validation strategies, test management and defect tracking tools such as Jira to write and execute test scripts, based on approved functional specification.

3. Proficiency in SDLC, Agile methodology, and GxP validation principles.

4. Familiarity with FDA 21 CFR Part 11, ICH E6 (GCP), HIPAA, and ISO guidelines.

5. Knowledge of SQL and C#.

6. National telecommuting.

Work Location: Philadelphia, PA.

Hours: 40 per week – Monday through Friday.

Send your resume to Madeline Ward, HR Coordinator at Madeline.ward@prevailinfoworks.com.