System One Contract Clinical Trial Manager in Florham Park, New Jersey
Contract Clinical Trial Manager
Locations: Hybrid work arrangements will allow work from home combined with your presence on-site 2-3 days/week at our US HQ in Florham Park, NJ.
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
Responsible for operational execution of global/regional Phase I-IV studies. Manages trial deliverables as well as CRO and vendor relationship and performance to ensure that clinical studies are completed in accordance with contract specifications and management’s expectations of time, cost and quality
Develops outsourcing specifications for vendor requests for proposal, leads vendor selection and oversees vendor management throughout the life of assigned clinical trial(s). Responsible for setting up, negotiating, and monitoring Task Order invoice payments for CRO and third-party vendors (direct service and pass through costs); as well as oversee 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 resource requirements (time, financial manpower) for study (ies) within agreed upon parameters and milestones
Delegates and manages tasks and responsibilities to other team members assigned to the study (ies).
In collaboration with the CRO/vendor oversees operational study level feasibility, recruitment strategies and the delivery of the approved study protocol
Provides review and input of 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 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
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 20% including possible international travel
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.