An experienced COM or Senior COM is required to join a Swiss based pharmaceutical company on a 12 month contract. This is a hybrid role with a requirement to work onsite near Basel 3 days per week. Please only apply to this role if you are an EU/EFTA citizen or hold a valid Swiss Work Permit.
Responsibilities will include:
* Managing 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 escalate 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
Candidate Requirements:
* At least 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 Harmonization-Good Clinical Practice (ICH-GCP) guidelines
For additional information and a confidential discussion, please apply now with an updated CV.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Consulting and Science
Industries
* Pharmaceutical Manufacturing and Biotechnology Research
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