We make it GmbH, placed in Reinach BL, is a Swiss Recruitment success story.
As one of the market leaders, We make it recruits specialists for project assignments as well as for permanent employments all over Switzerland - quickly, in accord with your needs and reliably.
We make it is specialized in following areas: Information Technology, Administration, Engineering, Finance and Pharma.
For our client, headquartered in Basel, Switzerland and one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics, we are continuous seeking for different temporary vacancies
Global Studies Manager
As an Global Studies Manager you provide the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate
quality standards including ICH/GCP and applicable regulations.
Major Responsibilities and Accountabilities:
You can: provide direction to one or more clinical operations team, also develop operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, clinical supplies management and maintain effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.
You have: experience contributing to the development and management of the study timelines, resources, budget, risk and quality plans
You provide: clinical operations expertise to ensure operational feasibility and delivery, the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
You will: oversee forecasting of clinical/non-clinical supplies and identify areas of best practice and process improvements, ensure study adherence to ICH/GCP and SOPs
You deliver: the operational elements of the study plan (meetings, reporting preventative action plans)
Additionally we are looking for the following qualifications and experience:
You have a life sciences degree or nursing equivalent, or substantial experience in a clinical research/ healthcare environment.
Has worked 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 of timelines, budgets and resource plans.
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.
You bring with you 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.
Please note we can only consider EU 25- or Swiss citizens for this job
Are you interested in this challengeing employment? Then forward your application form (in both PDF- & Word-Format) by e-mail to Mrs Cynthia Castiglioni or by post to the adress underneath.
If you require any further information, please do not hesitate to contact us.