Covance Clinical Operations Lead II, Associate Manager in Bangalore, India
Work Location: Bangalore
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
Essential Job Duties:
Understand and follow, provide input to and training of related project specific and Covance policies and procedures
Direct line management responsibility for Clinical and Ancillary Supply Services team members: the recruitment, training/development, allocation, supervision, utilization and performance review of assigned personnel
Effectively network with others throughout Covance
Serve as primary liaison between Clinical & Ancillary Supply Services, operational project teams, Covance Laboratory Services (CLS), distribution vendors, client distribution units, packaging and labeling vendors or assign relevant staff to carry out this function
Liaison with project teams and department members regarding issues of compliance with ICH/GCP, GMP, project plans, and Covance SOPs
Oversee coordination of study related Clinical and Ancillary Supply activation and maintenance components including Labels/Supply, Import/ Export requirements, ancillary supply management
Develop project specific plans for the Clinical and Ancillary supply component of assigned studies
Represent Clinical and Ancillary supplies component within a region or for complex global studies at client and internal project meetings
Anticipate and monitor project requirements and institute appropriate actions to ensure timelines and budget needs are met
Contribute to the development of processes, procedures, tracking systems and IT solutions for Clinical and ancillary supply activities
Assist in the preparation and presentation of services, costings and proposals for new business
Management of relevant portion of project budgets, including input into preparation of utilization reports (projected and actual) and implement measures to ensure accurate billing
Interact with internal and external work groups to evaluate and forecast workload and resource needs
Present at internal and external meetings including client meetings
Ensure appropriate communication on project-related matters with the clinical project team
Provide clinical and ancillary supply project related milestone information
Review and, in accordance with Covance standards and assigned authority, approve employee expense reimbursement.
Clinical trial supply and ancillary supply coordination:
Provide consultation pertaining to clinical & ancillary supplies: the labeling, tracking, specific national requirements, importation
Review IxRS specifications
Ensure triggering of drug shipments to investigational sites
Manage Drug distributor
Supervise development and review of Clinical Trial Supplies Plans
Review of and input to authority inspection and client audit findings or CAIRs
Develop, update and/or refine SOPs
Remain current with and provide updates to regional and local regulatory requirements related to clinical and ancillary supplies.
Remain current with industry innovations and advances, especially pertaining to clinical and ancillary supply matters so as to include relevant advances and technology into the design of trial strategies.
Perform other duties as assigned by management
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
DemonstratedRegulatory, GMP or QA experience.
Job Number 2018-17118
Job Category Clinical Operations
Position Type Full-Time
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