About Bodhi Global Solutions

BODHI GLOBAL SOLUTIONS is a highly competitive company – with innovation in global services solutions for businesses and organizations in the pharmaceutical and data management field. The consulting services, which the company offers, include, but not limited to the following: Data Management & Biostatical services consulting, Recruiting and Training.

BODHI provides superior program management, flexible solutions, proactive risk management, and productive partnering models. The company does this by utilizing performance determinant metrics not only to drive results, but also to design and execute our projects based on clients/customer goals. When it comes to Biostatistical services, the company is helping pharmaceutical companies worldwide with statistical analyses of manufacturing and clinical trial projects data.

In the project and data management, Bodhi focuses on result rather than exploring the daily technological bubbles. This way, clients are able to maximize the gains of their service partnership with the company in many fronts. From its wealth of cross-cultural and technical expertise, Bodhi offers its teaming clients, partners, and employees, a system that ensures they will receive a Return on Investment (ROI) and that all of the engaging partners of the company will achieve long term and sustainable growth that is profitable. We analyze and enable key elements in the managerial and technical aspects of their businesses. This way, we help companies to improve corporate performance.

Our integrated consulting services help pharmaceutical companies in data management, and our Biostatistical services help companies to spend less times in marketing. We help them manage risk, gain access into new global markets, and maximize portfolio value by leveraging on the latest technology. This way, companies are able to accomplish so much in less time. BODHI offers global regulatory compliance and validated services throughout the client requirements workflow. This way, clients are able to reap maximally from every of their investments into the workforce.

Its consulting services include data management, and bio statistical services, regulatory planning, providing customized and individualized skilled personnel for development operations, to ensure qualified validation for the new, and the existing clients. Actually, companies can draw from the Bodhi skilled personnel resources in two formats: the customized training model and the individual training model.

 

Clinical Research Associate

  • South San Francisco, CA
  • October 28, 2019
Essential Duties and Responsibilities:
Assist in managing and or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

  • Participate in and may facilitate cross-functional study teams, liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory affairs) to accurately coordinate clinical study activities
  • Coordinate clinical study timelines with Project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
  • Provide monitoring oversight by reviewing monitoring schedules, metrics and reports. May oversee or manage clinical documentation and reports
  • Accurately update and maintain clinical systems within project timelines
  • Provide regular updates of study progression to CTM, Clinical Development Lead, Program Management, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
  • Participate in developing study plans and system set-up; participate in the preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
  • Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance
  • Participate in the preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team
  • Work on study feasibility assessments and selection of countries and sites for study conduct
  • Create and conduct training sessions including investigator meetings and team trainings
  • Provide oversight and direction to study team members, including vendors, for study deliverables
  • All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs
Qualifications:

  • BA/BS degree with at least 4 - 6 years clinical trial management experience, or advanced degree (MS) with at least 4 years clinical trial management experience
  • Must have strong knowledge of ICH/GCP guidelines
  • Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
  • Strong experience in the management of CROs and other vendors
  • Proven project management skills and study leadership ability required
  • Must have excellent interpersonal, written and verbal communication skills, and administrative skills
  • Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
  • Ability to roll up your sleeves and individually contribute results to a research and development effort
  • Ability to travel up to 25%

Experience

4 to 7 (Yrs)

Required Skill Set

CRA ICH/GCP Guidelines Management Of CROs Clinical Drug Development Processes Clinical Study Design Study Planning Management And Monitoring

Salary

$80,000 - $110,000

Telecommute

No

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