Our client is a pioneer in Drug Discovery and Development. As the world`s largest R&D spender in the pharmaceutical domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. A leader in the field of manufacturing and selling of several drugs with treatment of Cancer. We are currently looking for an enthusiastic Global Studies Manager for a 12-months contract position to be based in Basel, Switzerland.
As a Global Studies Manager you will provide operational expertise and leadership to one or more cross-functional global Study Management Teams and ensure the timely and efficient delivery of all operational aspects of one or more studies through all phases and stages in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.
As an ideal candidate you should have 3+ years of experience managing global studies, strong vendor management experience and solid exposure managing clinical trials within the Neurology/Neuroscience and/or Immunology therapeutic areas.
- Providing direction and leadership to one or more global Study Management Teams (SMTs);
- Developing operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management;
- Leading identification and selection of vendors, ensuring appropriate cross-functional input is incorporated into the scope of work;
- Contribuiting 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);
- Establishing study milestones and ensures accurate tracking and reporting of study metrics such as initial recruitment projections;
- Providing clinical operations expertise to ensure operational feasibility and delivery:
- Leads 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);
- Overseeing forecasting of clinical/non-clinical supplies;
- 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;
- Ensuring the completion and finalization of any corrective and preventative action plans resulting from site audits;
- Coordinating responses to study questions or issues from Health Authorities;
- Providing the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work:
- Performing ongoing vendor management including negotiation of scope of work, budgets, performance management, and issue resolution;
- Ensuring study adherence to ICH/GCP and SOPs.
Qualifications and Experience:
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
- 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 in Neurology/Neuroscience and/or Immunology is highly preferred;
- At least 5 years of experience managing global studies;
- Experience of project managing operational aspects of a clinical study including development and management of timelines and budgets;
- Strong vendor/CRO management experience;
- Experience managing operational aspects of a clinical study, including development and management of timelines and budgets;
- Well-developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization;
- Fluency in English.