Job Abstract

Category

Clinical Development

Position Type

Contractor/consultant

Job Location

Hybrid

The Clinical Trial Associate (CTA), Clinical Operations will support the clinical project team in the operational execution of clinical trials.

The Clinical Trial Associate (CTA), Clinical Operations will support the clinical project team in the operational execution of clinical trials.

• Update and maintain clinical systems within project timelines and review files for accuracy and completeness
• Support the Clinical Operations team with ongoing conduct of studies including specific allocated study management tasks as defined by the Clinical Trial Manager (CTM)
• Support inspection readiness
• Prepare, handle and distribute of Clinical Trial materials and maintenance of tracking information
• Act as a central contact for the clinical team for designated project communications
• Schedule Project related meetings, attend operational team meetings, write and/or review meeting minutes, distribute minutes and follow-up actions
• Assist with preparation of meeting materials, presentations,
• Prepare, handle, distribute, file and archive clinical documentation and reports according to standard operating procedures. Assist with identification of potential clinical sites; maintain investigator lists
• Support organization of investigator meetings/advisory boards
• Review of study files periodically for accuracy and completeness
• Track and manage Case Report Forms (CRFs), queries and clinical data flow
• Utilize JDE system to monitor funds on existing purchase
• Manage tracking of all Clinical operations contracts generated (i.e. coding, approvals, filing, etc.) and associated invoices
• Other duties as assigned

• BS/BA in Life Sciences preferred or demonstratable equivalent work experience
• Minimum 1-year pharmaceutical industry experience in clinical development involved with Clinical Trials
• Must possess basic knowledge of applicable clinical research regulatory requirements including, Good Clinical Practices (GCP)
• Must have basic knowledge of applicable protocol requirements
• Experience with invoice review and processing

• Strong written and verbal communication skills
• Strong Computer skills including proficiency in use of Microsoft Word, Excel and
• Effective time management and organizational skills
• Self-starter, problem solver, self-motivated, actively seeks to increase responsibility
• Background should include experience with calendar management; invoice review, budget management; meeting planning
• Attention to detail and accuracy in work
• Strong customer service
• Must live a commutable distance to our US Corporate Headquarters in Florham Park,

ESSENTIAL PHYSICAL REQUIREMENTS

• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time.
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time – up to four (4) hours at a time.
• Ability to lift, tug, pull up to fifteen (15) pounds.

You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.

DISCLAIMER

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.

You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.

It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.