The world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system is currently recruiting for a Global Studies Manager at their office in Switzerland.
Job Responsibilities:
- Providing operational expertise and leadership to one or more cross-functional global Study Management Teams (SMTs).
- Ensuring the timely and efficient delivery of all operational aspects of one or more studies through all phases (phase 1b-IV) and stages (start-up, conduct and close-down), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.
- Developing operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
- Building and maintaining effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
- Developing and maintaining effective working relationships with Study Management Team (SMT) members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.
- Collaborating with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members.
Contributes to the development and management of the study timelines, budget, risk and quality plans:
- Ensuring operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the Global Studies Leader (GSL).
- Developing and managings clinical study budgets (including HQ budget). Communicates variances in the budget and action plan for resolution to the GSL.
- Establishing study milestones and ensures accurate tracking and reporting of study metrics such as initial recruitment projections.
- Providing operational input into the development of protocol feasibility questionnaires.
Provides clinical operations expertise to ensure operational feasibility and delivery:
- Leading the development and finalization of site feasibility questionnaires.
- Leading the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and Operational Program Leader (OPL).
- Providings operational input and insight into all study related documentation (including protocol and informed consent form) and processes.
Oversees forecasting of clinical/non-clinical supplies:
- Designing drug assumption and supply chain process in partnership with Drug Supplies, affiliates and GSL.
- Overseeing the forecasting and management of non-clinical supplies to ensure sites have supplies to run a clinical study.
- Chairing operations team meeting and organizes investigator meetings, monitor training, CRO kick-off meetings.
- Ensuring that the reporting process of SUSARs is established and maintained for the duration of the study.
- Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL and implements contingencies in consultation with key stakeholders.
- Primary contact with affiliates to maintain oversight of performance, issues, their resolution and coordinates any corrective action.
- Actively partner with Data Management and Clinical Science to oversee eCRF completion and data quality issues.
- Performing ongoing vendor management (e.g., CROs, Central Labs, IxRS, etc.), including negotiation of scope of work, budgets, performance management, and issue resolution.
- Developing and supporting appropriate site and CRO/vendor audit and quality plans.
Skills and Requirements:
- Life sciences degree or nursing equivalent.
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock.
- Experience of project managing operational aspects of a clinical study including development and management of timelines and budgets.
- Good knowledge of ICH GCP.
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
- Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Anna Bigiotti at +44 0203 854 2470 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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