Clinical Trial Manager
- Posted: January 23, 2023
Trial Manager, Clinical Operations
New Jersey, NJ
The Trial Manager, Clinical Operations is responsible for conduct of global clinical studies. With minimal oversight, manages CRO and vendor performance to ensure that clinical studies are completed in accordance with contract specifications and management’s expectations.
Oversee and manage all operational aspects of phase I – IV global clinical trials in order to achieve a high quality product for the marketplace and business success.
+ Manage external partners, consultants, vendors and budget to ensure the timely and cost-effective implementation of clinical trials.
+ Coordinate the assessment of CROs and preferred vendors for implementation of clinical development plan. Review contracts, work orders and invoices prior to submission to senior management for approval.
+ Establish and maintain effective communication and collaboration with functional area peers including Pharmacovigilance, Drug Supply, Quality Assurance, Regulatory Affairs, Legal, Medical Writing, Biostatistics and Data Management to meet program objectives and support achievement of goals.
+ Responsible for resource requirements (time, financial, manpower) within Clinical Research and management within agreed upon parameters.
+ Responsible for completeness and accuracy of the study synopsis, protocol, case report and informed consent forms, clinical study reports, Annual Reports, and IB.
+ Responsible for leading protocol and study specific clinical and operational meetings.
+ Contribute to and support selection of all study-related vendors.
+ Accountable for working closely with Biometrics, Data Management, Pharmacovigilance and the CRO (when appropriate) to complete data management and bio-statistical analysis and oversee adherence to study timelines and data quality. Oversight includes the following areas:
query resolution, logic edit checks, data line listing review, QA/QC of adverse events, and serious adverse event processing.
+ Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close out, and completion of Trial Master File.
+ Responsible for initial RFP obtainment and contributes to CRO/vendor selection
+ Responsible for setting up, negotiating, and monitoring Task Order invoice payments for CRO (direct service and pass through costs); as well as oversee scope change negotiations.
+ Responsible for negotiating site CTAs in conjunction with the Legal Department and CRO.
+ Responsible for patient recruitment and retention plans
+ Responsible for the set-up of all third party vendor specifications (ie. IWRS, eCRF, central laboratory/ECG, etc.) and on-time third party deliverables.
+ Responsible for collecting, preparing and reviewing regulatory documentation for IRB submission prior to study start-up.
+ Responsible for participating and presenting at Investigator Meetings.
+ Responsible for program level budget forecasting and quarterly review.
+ In conjunction with Drug Supply, responsible for assuring sufficient clinical drug supply is packaged, available and shipped to sites for study start up, and that sufficient supply are maintained during the study.
+ Responsible for assuring accurate drug accountability/reconciliation for IP issued during the study to the site and at the end of the study.
+ In conjunction with CRO responsible for assuring sufficient ancillary supplies are available and shipped for the study (i.e., templates, binders, forms, supplies, etc.).
+ Responsible for preparing and/or presenting executive management slide decks.
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.
AddressFlorham Park, NJ
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