Covance Start-up Specialist I in Mexico

Job Overview

*Deliver of Global Site Services component of assigned studies within a country or globally. Including accountability for delivery to time, cost and quality for assigned activities.

  • Primary contact within investigative sites during site start-up activities.

  • Responsible for working with investigative sites to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor.

  • Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.

  • Work with staff in Operational Strategy & Planning Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials.

  • Where applicable, provide logistical support of clinical trial supply coordination.

  • Liaise with Sponsor and Covance regulatory regarding document submission requirements

  • Assess impact of changes in study personnel and document amendments on regulatory documents

  • Attend ongoing trainings

  • Monitor performance of start-up team with regard to project timelines

  • Prepare new investigator submission packages

  • Assess impact of study amendments on Informed Consent and other study documents

  • Other tasks and duties as assigned by Management.

Education/Qualifications

  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).

  • Knowledge of science or a scientific background is preferred.

  • Advanced knowledge of computers and programs (e.g., word processing, excel, power point)

  • Ability to work in a fast-paced setting with many interruptions.

  • Requires great attention to detail.

Experience

At least 2 years of relevant clinical research experience in a pharmaceutical or CRO industry position with similar tasks and responsibilities.

Strong networking capabilities

Good organizational and time management skills

Excellent communication and writting skills

Strong computer and technological skills

Self-motivation and learning with the hability to work under pressure to meet project timelines

Works well independently and within a matrix environment

Positive attitude and approach

Multi-tasking capabilities

Job Number 2018-19831

Job Category Clinical Operations

Position Type Full-Time

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