Clinical Operations Manager
CK QLS is recruiting for a Clinical Operations Manager for a global pharma company based near Basel on a 12 month contract basis.
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 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
- Mentor TEAM MEMBERS as needed
- Assume responsibility for other project or trial-related duties as assigned
Candidate Requirements:
- 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 Harmonization-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
- Position may require international travel
All candidates must have a EU/EFTA Citizen or valid Swiss work Permit to apply to this role.