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Your Responsibilities
* Manage the operational trial related activities in close collaboration with other functions, such as: site initiations, site closures, import/export licenses for materials and IMP, eTMF set-up and maintenance, contracts execution and invoices, submissions to Health Authorities, submissions to Ethics Committees/Institutional Review Boards (ECs/IRBs), timely completion of electronic Case report Forms (eCRFs), Source Data verification (SDV) progress and query responses timelines.
* Manage the selection of ESPs in collaboration with other functions.
* Lead the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables.
* Supervise the deliverables towards the Contract Research Organization (CRO) and ESPs selected for the trial, to ensure compliance with study protocol and in accordance with scope of work .
* identify areas of concern and elevate to the Clinical Trial team (CTT).
* Lead the development of trial-related operational documents.
* Consolidate information on operational clinical trial level activities for reporting to the CTT by the Senior Clinical Operations Manager (including critical issues and key performance indicators).
* Resolve operational issues in a proactive and timely fashion.
* Act as the communication channel for the Clinical Research Associates (CRAs) to ensure data quality is maintained, in close collaboration with other CTT functions.
* Approve invoices (e.g., site payments) and ensure related payments in a timely manner.
* Contribute to the Study Master File (StMF) completeness and readiness for audit/inspection and by performing ongoing quality checks/review.
* Actively participate to Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits, as necessary.
* Mentor TEAM MEMBERS as needed.
* Assume responsibility for other project or trial-related duties as assigned.
Your Profile
* Bachelor of Science degree or equivalent University degree in life sciences or healthcare.
* 4 years of experience in managing operational aspects of Phase II and Phase III trials and executing a wide range of clinical trial activities from study start up to clinical study report.
* Experience in working in global cross-functional (matrix) and multicultural teams.
* Experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management.
* Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS).
* Excellent knowledge of International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines.
* Strong computer skills including proficiency in Microsoft (MS)-based applications (e.g., Word, Excel, and PowerPoint).
* Excellent verbal and written communication skills in English; strong cultural knowledge of national diversities.
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