Covance has an exciting opportunity for a Senior Specialist with the Clinical & Ancillary Supplies Services team. This role can be home based within the United States or EMEA.
The Clinical & Ancillary Supplies Services (CASS) Senior Specialist:
- Coordinate and oversee aspects of logistics related to Clinical and Ancillary Supplies services. Support these services to both internal and external clients.
- Responsible for the set-up and coordination of project activities related to clinical and ancillary supplies
- Independently support the delivery of the Clinical and Ancillary supplies component of assigned studies within a region or for a large global study.
- Provide local support with clinical and ancillary supplies start up activities and related project feasibility
- Act as a subject matter expert (SME) related to import, export and labeling requirements.
- Work with staff in Clinical Trial Design & Strategy, Vendor Management, Quality Assurance, Business Development and Operations, to provide relevant clinical and ancillary supply data critical to the ability of the organization to develop plans for the successful implementation and conduct of global clinical trials.
- Assure that pre-study, drug supply and labeling processes comply with applicable guidelines and regulations and fulfill client and Covance requirements.
- Provide logistical support for clinical and ancillary supply coordination.
- Provide input into business development activities.
- Act as a subject matter expert (SME) in client focused clinical and ancillary supply workstreams.
- University/College Degree (preferably postgraduate degree) AND 4 years relevant clinical research/GMP experience
- Thorough understanding of global drug development and the clinical trial project management process, with a special emphasis on investigator sites, patient recruitment and retention
- Thorough and practical working knowledge of ICH-GCP Guidelines, Clinical GMP, including relevant international requirements/guidelines for the conduct of global clinical development programs
In lieu of the above requirements, candidates with > six (6) years clinical research experience including monitoring in the pharmaceutical or CRO industries will be considered.
- 3 years Experience in Clinical Supply distribution/ GMP environment
- An understanding of aspects surrounding Covance business development (time and cost estimates, bid defense, contracts)
- An understanding of Covance procedures, including Standard Operating Procedures
- Minimum of 4 years relevant clinical research experience in a pharmaceutical company/CRO, including at least 2 years of clinical and ancillary supplies management responsibility.
- Very strong technical writing skills and analytical skills
- Strong networking abilities and an ability/willingness to work with individuals across the globe
- Excellent communication, planning & organizational skills
- Ability to inspire, to lead by example and motivate teams to seek solutions and get results
- Strong abilities to negotiate and liaise with customers in a professional manner
- Experience in end to end (full service) clinical trial management, ideally with global project management experience
- Abilities to review/analyze relevant data so as to build evidence-based clinical trial strategies
- Abilities to design/develop effective strategies to bring about trial success, as defined by clients and project teams through the use of an evidence-based approach.
- Strong computer skills with an ability to understand and access and leverage technology alternatives.
- Ability to work independently
- 2-4 years Clinical Supply Project Management logistics experience
- Demonstrated Regulatory, GMP or QA experience.