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Clinical Operations Manager

Website Achieva Group Limited

Clinical Operations Manager
Work Location: Basel
Country: Switzerland
Business Area: Global Clinical Development
Schedule: Fulltime (100%)
Desired start date: ASAP
Duration: 12 months
Contractor Rate: CHF 69.49

Job Responsibilities
The Clinical Operations Manager is driving the development of the operational trial related documents and procedures, as well as setting-up the ESPs and supervising the deliverables of all ESP related activities, from specifications to close-out. For large Phase III or complicated trials, several Clinical Operations Managers might be assigned to a trial for the management of ESPs.

• 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’s 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

Behavioral Skills

• Strong interpersonal, communication (written and verbal), collaboration and organizational skills
• Self-motivated and able to work independently and proactively
• Goal-oriented, able to effectively prioritize and execute tasks in a high-pressure environment
• Demonstrate ownership and initiative, decision-making, working flexibility and problem-solving skills
• Demonstrate ability to work in multi-functional and cross-functional teams: effective teamwork and collaborative relationships
• Able to share expertise and experience with team members and across teams

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