"Alerted.org

Description

• Perform feasibility analysis for studies

• Conduct literature review

• Plan observational studies and draft protocol synopsis (or protocol concept sheet)

• Determine observational study design criteria – including source data, analytical methods and analysis plans

• Draft and review observational study protocols

• Draft and review observational study analysis specifications, including statistical analysis plans (SAPs)

• Draft and review observational study reports

• Conduct observational studies, both primary data collection and secondary data use studies

• Conduct study data analysis according to observational methods

• Conduct data analysis according to observational methods

• Review analysis outputs for quality, including study analysis, ad hoc analysis, analysis to support conference or publications

• Conduct quality review of all deliverables to ensure data and results are accurate

• Work with scientific and operational stakeholders to identify and resolve issues

• Collaborate with study teams, vendors and other stakeholders to advance study and analysis deliverables

• Work with relevant stakeholders to meet study milestones and timelines

• Participate in program or study planning meetings

• Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks

• Contribute to ongoing improvement of programming processes and methodology

• Perform other related duties as required by the Department.

Additional Skills & Qualifications

• Experience in providing thought leadership and consistent customer service

• Expertise in the end-to-end sourcing and contracting process, including RFx, contract negotiation and management

• Demonstrates an in-depth knowledge of the clinical research process and the regulatory environment across functions

• Demonstrated leadership skills while working in fast paced and changing environment

• Financial acumen to review, analyze and understand cost drivers of complex budgets

• Legal, clinical operations and regulatory acumen

• Travel may be required

Knowledge, Experience and Skills:

• Relevant experience with a BA or MS in a relevant discipline

• MBA or JD preferred

• PMP/CPSM certification or equivalent a plus

Experience Level

Expert Level

Pay and Benefits

The pay range for this position is $120.00 - $133.33/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Foster City,CA.

Application Deadline

This position is anticipated to close on Jun 9, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.