Clinical Trial Manager, Clinical Operations

Overview:

Responsible for overseeing and managing insourced or outsourced studies including all operational aspects of assigned phase I – IV clinical trial(s), whilst ensuring patient safety, data quality and integrity.

Responsibilities:

• Responsible for operational execution of global/regional Phase I-IV studies in accordance with budget and timeline. Manages trial deliverables as well as CRO and vendor relationship and performance. Drives the development of outsourcing specifications for vendor requests for proposal, leads vendor selection and oversees vendor management throughout the life of assigned clinical trial(s).
• Contribute to setting up and negotiating Task Orders as well as scope change negotiations. Oversees overall study level budget and appropriate invoices for all vendors
• Oversees study activities including study start-up, close out, and completion of Trial Master File. Ensures oversight of clinical trials including the selection of investigational sites, adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with study/ site personnel. Monitor all vendors/ CRO performance, communicate vendor expectations, and track vendor performance metrics
• Responsible for overseeing negotiation of site CTAs in conjunction with the Legal Department and CRO/contracts vendor
• Responsible for assessing resource requirements (time, financial manpower) for assigned study (ies)
• Manages study tasks and responsibilities directly or through effective delegation to other team members assigned to the study (ies).
• In collaboration with the CRO/vendor oversees operational study level feasibility, recruitment and retention strategies and the delivery of the study protocol
• Provides review of and input to selected study clinical documents (protocol, operational plans, monitoring plans, monitoring visit reports, etc) based on SOP, ICH/GCP guidelines and with patient centric view
• Responsible for overall risk management of study to assure timely delivery to quality, budget and time. Escalates issues to stakeholders as appropriate and ensures successful implementation
• Leads or supports inspection readiness activities. Participates as appropriate in internal and external audits. Facilitate internal audit/corrective and preventative action (CAPA) management and contributes to the resolution of CAPA
• Plans and conducts study related meetings including investigator meetings and ad boards.
• In collaboration with data management, facilitates ongoing data review for trends and quality and in preparation for interim, final analyses and review of CSR
• Responsible for providing program director regular status updates
• Establish and maintain effective communication and collaboration with functional area peers in order to meet program objectives, proactively identify study risks and support achievement of goals
• Participates in SOP development as reviewer of local or global documents. Supports development and improvement of departmental and company procedures and shares best industry practice
• Mentor project team members regarding project specific activities, reporting and tools
• Other duties as assigned

• Decision making for conduct of assigned study(ies) in accordance with company SOPs

• BA/BS in life sciences or equivalent; At least 4 years of clinical research experience including at least two (2) years having effectively led a study/studies project from inception to completion coupled with demonstrated ability to hold team members accountable. Global experience of drug development ideally obtained in a biotech/pharma setting
• Working knowledge of Good Clinical Practices (GCP), EU Clinical Trials Directive / Regulation and expectations for MHRA GCP Inspections. Awareness of FDA regulations and guidelines with respect to clinical trials, and applicable international regulatory requirements
• Knowledge of clinical operations, project management tools and processes. Ability to effectively manage interactions with investigators ensuring cooperation for achieving program goals
• Knowledge of pharmaceutical business, drug development and regulatory processes
• Ability to resolve problems and lead projects of diverse scope, analyze data and exercise sound judgment along with the ability to recommend business alternatives to senior management
• Proficient MS Office skills including data review analysis tools
• Ability to travel up to 10% including possible international travel

• Strong written and verbal communication skills along with excellent interpersonal skills and proven ability to interface effectively with diverse development teams
• Prior global experience
• Ability to effectively multi-task
• Attention to detail and accuracy in work
• Strong decision-making skills and ability to use independent judgment to quickly set priorities solve problems and resolve conflict.
• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.

• 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
• 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

EEO:

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.