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Clinical Trials Management Associate - III

Netpace, Inc Foster City ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

 

  • Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas. With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required. Assures site compliance with the routine protocol and regulatory requirements and quality of data. Assists in the setting and updating of study timelines.
  • Assists in CRO or vendor selection. With guidance from supervisor coordinates CROs or vendors. Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans. Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
  • Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams. May participate in abstract presentations, oral presentations and manuscript development. Interfaces with individuals in other functional areas to address routine study issues.
  • May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants. Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives. Travel is required.Excellent verbal, written, interpersonal and presentation skills are required.
  • Working knowledge and experience with Word, PowerPoint and Excel. Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials. Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
  • Ability to develop tools and processes that increase measured efficiencies of the project. Must be able to anticipate obstacles and proactively develop solutions to achieve project goals. Must have a general understanding of functional issues and routine project goals from an organizational perspective.
  • Senior CTMA Job Responsibilities
  • Must be familiar with routine medical/scientific terminology
  • Under supervision may assist in review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports
  • May contribute to SOP development
  • Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs
  • May monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required
  • May resolve routine monitoring issues
  • Must be familiar with good documentation practices and electronic trial master file system
  • Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
  • Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams
  • Must be able to anticipate obstacles and proactively develop solutions to achieve project goals
  • Must have a general understanding of functional issues and routine project goals from an organizational perspective
  • May participate in abstract presentations, oral presentations and manuscript development.
  • Interfaces with individuals in other functional areas to address routine study issues
  • Ability to develop tools and processes that increase measured efficiencies of the project
  • May be asked to assist in the training of CTMAs and CPAs
  • Assists in CRO or vendor selection
  • Coordinates CROs or vendors
  • Assists in the setting and updating of study timelines
  • May participate in departmental or interdepartmental strategic initiatives under general supervision in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
  • May conduct site evaluation, initiation, co-monitoring, and closeout visits in addition to routine monitoring visits, as required
  • Assures site compliance with the protocol and regulatory requirements
  • Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans
  • Excellent verbal, written, interpersonal and presentation skills are required
  • Knowledge of FDA and or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
  • Working knowledge and experience with Word, PowerPoint and Excel
Company Description
Netpace is a data-driven provider of AI, Block Chain, Analytics and Cloud Enablement solutions to Fortune 500 companies. and support our Pharma Clients with various positions starting from IT to Clinical Phase I-III/Post Marketing. Our data-centric services and solutions are used to drive digital transformations and empower our customers to make highly informed business decisions.
Our client is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Client therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions..

Netpace, Inc

Why Work Here?

One Of Fastest Growing Firm in Pharma/IT Staffing Industry.

Netpace is a data-driven provider of AI, Block Chain, Analytics and Cloud Enablement solutions to Fortune 500 companies. and support our Pharma Clients with various positions starting from IT to Clinical Phase I-III/Post Marketing. Our data-centric services and solutions are used to drive digital transformations and empower our customers to make highly informed business decisions. Our client is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Client therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions..

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333 Lakeside Drive
Foster City, CA
USA

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