Actalent Clinical Study Manager in Tarrytown, New York
Clinical Study Lead (CSL), you will lead the cross-functional study team responsible for the global execution of large, complex clinical trials from study design through study close out. These responsibilities apply to both internally sourced studies and studies outsourced to CROs. This is an exciting time to join our organization and have a direct impact on bringing life-saving treatments to the market.
Leading 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 and protocols
Supervising set-up and maintenance of study systems such as Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
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
Supervising study close-out activities and contributing to clinical study report writing and review
Additional Skills & Qualifications:
Global experience is a must (leading studies from start up through closure) - global phase IV is ideal
5+ Global Clinical Trial Management Experience (Pharmaceuticals /Clinical Research Organization / Biotechnology)
Experience managing multiple studies at once - doing updates, working with CRA's, IRB submissions, etc.
4 year degree minimum
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. We’re 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.
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