Global Trial Lead
The Global Trial Lead 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.
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.
- 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.
- 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.
- Mentor TEAM MEMBERS as needed.
Candidate's Requirements:
- Bachelor of Science degree or equivalent University degree in life sciences or healthcare.
- 10 years of experience in managing operational aspects of complex Phase II and Phase III clinical trials and global teams.
- At least 3 years of experience as a Sr COM or other equivalent position in previous working history.
- Experience in leading global cross-functional (matrix) and multicultural teams.
- Experience in leading cross-functional teams is appreciated.
- Previous involvement in high complexity trials, with ability to overcome challenges and impact study conduct.
- Ability to represent Clinical Operations in high level Clinical Development meetings.
- Intensive experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management.
- Experience working with electronic data capture, electronic Trial Master File and Clinical Trial Management Systems.
- Excellent knowledge of ICH-GCP.
- Advanced computer skills (e.g., Microsoft Office, Word, Excel and Power Point).
- Excellent verbal and written communication skills in English; strong cultural knowledge of national diversities.
- Position may require international travel.
Apply:
If you are interested, you can send a CV in English at aguimard@ckqls.ch.
It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 137 025 in all correspondence.