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Senior Clinical Study Manager

Company: Actalent
Location: Basking Ridge
Posted on: September 23, 2022

Job Description:

Company:A multi-billion dollar company who is currently leading the industry with 9 marketed drugs and a robust pipeline containing multiple trials in phases I-III. In addition, 100% of their drug candidates are invented and developed in house. Role:Sr Clinical Trial Manager Hybrid - 2 days onsite, in either Basking Ridge NJ or Tarrytown NY Overview: Clinical Study Lead (CSL) for Phase IV Non-Interventional Studies, you will lead the cross-functional study team responsible for the global execution of Non-Interventional, Observational company sponsored clinical trials (e.g., Registries, post-authorization safety studies (PASS), PMR, DUS, evaluation of REMS and risk minimization measures, regulatory agency required non-interventional efficacy studies (e.g. PAES)). Responsibilities apply to both internally sourced studies and studies outsourced to CROs, so we need a SCSL who has experience managing Third-Party Vendors. We need someone who can also contribute to and drive process improvement initiatives that support our rapidly growing organization. This is an exciting time to join our organization and have a direct impact on bringing life-saving treatments to the market. Job Description: Providing operational input into protocol development Leading all aspects of and contributing to the development of study specific documentation e.g. case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Supervising set-up and maintenance of study systems such as Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensuring compliance with the clinical trial registry requirements Providing input into baseline budget and timeline development and managing the study against planned budget, timeline and results Leading risk assessment and identifies risk mitigation strategies at the study level Managing feasibility assessment to select relevant regions and countries for the study Conducting site evaluation and selection Leading investigator meeting preparation and execution Monitoring progress for site activation and monitoring visits and acts on any deviations from plan Managing development and implementation of patient recruitment and patient retention strategies Monitoring data entry and query resolution and taking action on any divergence from agreed metrics Overseeing and providing input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Raising issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other partners and developing and implementing appropriate actions to address issues Ensuring data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Ensuring clinical project audit and inspection readiness through the study lifecycle and contributing to CAPAs as required Skills: Vendor Management, Global Trial, Clinical Research, Clinical Trial, Phase IV, Clinical Study, Clinical Operation, Cro, Sop, Timeline, clinical trial management, late phase Top Skills Details: Vendor Management, Global Trial, Clinical Research, Clinical Trial, Phase IV Additional Skills & Qualifications: Bachelors degree and minimum of 8 years relevant industry experience. advanced degrees may be considered in lieu of relevant experience Late Phase/Phase IV/Observational/Non-interventional Experience highly preferred You have direct management experience with demonstrated results building and developing outstanding teams About Actalent:Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Newark , Senior Clinical Study Manager, Executive , Basking Ridge, New Jersey

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