Covance Clinical Operations Associate in Bangalore, India
Work location: Bangalore
The Clinical & Ancillary Supplies Services (CASS) Associate:
Support of the Clinical and Ancillary supplies component of assigned studies within a country or regionally. Including accountability for delivery to time and quality for assigned activities.
Support contact with study team during clinical and ancillary start-up activities including support to the development of Clinical Trial Supplies Plan or Clinical Trial Supply Flow
Support in label review and country translations according to set procedures for regional or simple global study.
Work with project team to ensure the required documents and processes related to supply management are obtained.
Where appropriate provide support for importation logistics and document exchange to ensure smooth clinical supply transportation arrangements are agreed and set up.
Support maintenance of project specific clinical & ancillary supply logistics.
Interact with drug and ancillary supply distribution, IVRS/IRT and label translation vendors during the set up and maintenance of related logistics
Essential Job Duties:
Review, read and apply project specific plans for the Clinical and Ancillary supply component of assigned studies
Support Clinical and Ancillary supplies component at client and internal project meetings
Liaise with operational project team regarding local supply related project issues
Support Covance Clinical & Ancillary Supply team member/ PM regarding clinical supply related submission requirements
Attend ongoing training, project specific requirements and as may generally be required
Provide milestone information for incorporation into weekly analysis sheets
Perform administrative tasks required during study start up activities (e.g., word processing, assembly of study documents, mass mailings, filing, faxing/photocopying)
Understand and follow project specific and Covance policies and procedures
Communicate with the drug and ancillary supply vendors as applicable
Support importation logistics and document exchange to ensure smooth clinical supply transportation arrangements are agreed and set up.
Support drug supply labels development as applicable
Support coordination of ancillary supply logistics with various vendors or internal team
Assist with preparation of materials for formal client/industry presentations and for internal training assignments
Assist with entering data into spreadsheets when required
Conduct QC of documents as required by the process
Undertake literature and internet searches as required
Perform other duties as assigned by management
University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).
In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered.
Prefered: 1 year Experience in Clinical Supply distribution/ GMP environment
Working knowledge of ICH, FDA, GMP and other applicable regulations/guidelines; familiarity with clinical supply related documents
Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
Good organizational and time management skills
Excellent communication / writing skills
Strong computer skills with an ability to access and leverage technology alternatives
Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
Self-motivation with the ability to work under pressure to meet deadlines
Works well independently as well as in a team environment
Detail and process oriented
Positive attitude and approach
Ability to work independently
Job Number 2018-17116
Job Category Clinical Operations
Position Type Full-Time
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