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.