Covance Start-up Specialist I in Mexico
*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.
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.
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
Job Number 2018-19831
Job Category Clinical Operations
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.