Covance has an thrilling alternative for a Senior Specialist with the Scientific & Ancillary Provides Providers group. This function might be dwelling based mostly inside the US or EMEA.
The Scientific & Ancillary Provides Providers (CASS) Senior Specialist:
- Coordinate and oversee features of logistics associated to Scientific and Ancillary Provides providers. Assist these providers to each inner and exterior shoppers.
- Liable for the set-up and coordination of challenge actions associated to scientific and ancillary provides
- Independently assist the supply of the Scientific and Ancillary provides element of assigned research inside a area or for a big world examine.
- Present native assist with scientific and ancillary provides begin up actions and associated challenge feasibility
- Act as a topic knowledgeable (SME) associated to import, export and labeling necessities.
- Work with workers in Scientific Trial Design & Technique, Vendor Administration, High quality Assurance, Enterprise Growth and Operations, to offer related scientific and ancillary provide information important to the power of the group to develop plans for the profitable implementation and conduct of world scientific trials.
- Guarantee that pre-study, drug provide and labeling processes adjust to relevant tips and laws and fulfill consumer and Covance necessities.
- Present logistical assist for scientific and ancillary provide coordination.
- Present enter into enterprise improvement actions.
- Act as a topic knowledgeable (SME) in consumer targeted scientific and ancillary provide workstreams.
- College/School Diploma (ideally postgraduate diploma) AND 4 years related scientific analysis/GMP expertise
- Thorough understanding of world drug improvement and the scientific trial challenge administration course of, with a particular emphasis on investigator websites, affected person recruitment and retention
- Thorough and sensible working information of ICH-GCP Tips, Scientific GMP, together with related worldwide necessities/tips for the conduct of world scientific improvement packages
In lieu of the above necessities, candidates with > six (6) years scientific analysis expertise together with monitoring within the pharmaceutical or CRO industries can be thought-about.
- 3 years Expertise in Scientific Provide distribution/ GMP surroundings
- An understanding of features surrounding Covance enterprise improvement (time and value estimates, bid protection, contracts)
- An understanding of Covance procedures, together with Commonplace Working Procedures
- Minimal of 4 years related scientific analysis expertise in a pharmaceutical firm/CRO, together with at the very least 2 years of scientific and ancillary provides administration duty.
- Very sturdy technical writing expertise and analytical expertise
- Sturdy networking skills and a capability/willingness to work with people throughout the globe
- Glorious communication, planning & organizational expertise
- Skill to encourage, to guide by instance and encourage groups to hunt options and get outcomes
- Sturdy skills to barter and liaise with prospects in an expert method
- Expertise in finish to finish (full service) scientific trial administration, ideally with world challenge administration expertise
- Talents to evaluation/analyze related information in order to construct evidence-based scientific trial methods
- Talents to design/develop efficient methods to result in trial success, as outlined by shoppers and challenge groups by way of the usage of an evidence-based strategy.
- Sturdy pc expertise with a capability to grasp and entry and leverage know-how alternate options.
- Skill to work independently
- 2-4 years Scientific Provide Venture Administration logistics expertise
- Demonstrated Regulatory, GMP or QA expertise.