Clinical Operations Manager
The Clinical Operations Manager is driving the development of the operational trial related documents and procedures, as well as supervising the deliverables of all External Service Providers (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 and handling of operations deliverables.
- Contributes to 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, ESPs/Clinical research organizations selection and management, submissions to Health Authorities and IECs/IRBs, eCRF completion by sites and SDV status, etc.
- Manages the selection of ESPs in collaboration with other functions
- Leads the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables.
- Supervises 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 Clinical Trial Team (CTT).
- Leads the development of trial-related operational documents
- Consolidates information on operational clinical trial level activities for reporting to the CTT by the Sr Clinical Operations Manager (including critical issues and key performance indicators).
- Resolves operational issues in a proactive and timely fashion
- Acts as the communication channel for the CRAs to ensure data quality is maintained, in close collaboration with other CTT functions, and ensure the CRAs are properly trained on the clinical trial requirements.
- Approves invoices (e.g., site payments) and ensure related payments in a timely manner.
- Ensures adequate trial-specific training of assigned ops team and CRO/ESPs.
- Ensures Study Master File (StMF) completeness for audit/inspection readiness and contributes by performing ongoing quality checks/review.
- Actively participates to Investigators meeting preparation and presentations and in Site Selection Visits (SSVs) and Site Initiation Visits (SIVs), as necessary.
- Supports business unit/departments in internal audit preparations and during audits, and ensure the follow-up of and resolution of audit findings.
- Mentors team members as needed.
- Assumes responsibility for other project or trial-related duties as assigned.
Qualifications and Experience:
- Bachelor of Science degree or equivalent University degree in life sciences or healthcare
- 5 years of experience in managing operational aspects of Phase II and 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 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 ICH-GCP
- Advanced computer skills (e.g., Microsoft Office, Word, Excel and Power Point)