Global Study Manager
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 drugs & therapeutic areas and are highly recognized internationally. They are also a leader in the field of manufacturing and selling of several drugs for the treatment of Cancer.
We are currently looking for Global Study Manager on a contract basis to join our client at Basel area. If you have at least 2 years of experience , working in pharmaceutical or CRO environment managing studies at global level and solid experience in vendor management, this is the right opportunity for you!
As a Global Study 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.
- Develop operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management;
- Build effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables;
- Develop and maintain effective working relationships with study management team members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams;
- In collaboration with functional management, coach, mentor, support, and provide study specific direction to Study Management team members;
- Responsible for leading identification and selection of vendors; ensuring appropriate cross-functional input is incorporated into the scope of work;
- Responsible for assessing feasibility of and driving execution/adherence to protocol amendments or changes to clinical studies, across functions;
- Responsible for leading identification and selection of vendors; ensures appropriate cross-functional input into the scope of work;
- Contribute to the development and management of the study timelines, resources, budget, risk and quality plans;
- Ensure operational tracking tools are identified, including systems to meet the needs of the operations team and ensure reporting to the Global Study Leader;
- Develop and manage clinical study budgets (including HQ budget) and contribute to staffing/resourcing plans;
- Provides operational input into the development of protocol feasibility questionnaires;
- Leads the development and finalization of site feasibility questionnaires;
- Establish study milestones and ensures accurate tracking and reporting of study metrics;
- Lead 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 Global Study Leader and Operations Program Leader;
- Oversee forecasting of clinical/non-clinical supplies;
- Design drug assumption and supply chain process in partnership with Pharma Technical Drug Supplies, affiliates and Study leaders;
- Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings;
- Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits;
- Primary contact with affiliates to maintain oversight of performance, issues, and their resolution and coordinates any corrective action;
- Actively partner with Data Management and Clinical Science to oversee eCRF completion and data quality issues;
- Oversees the maintenance of drug supplies and resolution of issues with input from the Drug Supplies;
- Coordinates responses to study questions or issues from Health Authorities;
- Provides operational input into the development and tracking of SMT goals;
- Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs;
- Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution;
- Participates in Product Development Global Operations initiatives and programs as assigned;
- Maintains oversight and ensures consistency of the operational aspects across studies within a project.
Qualifications and Experience:
- 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 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;
- 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;
- Fluent in both written and spoken English;
- Relevant working/residency permit or Swiss/EU-Citizenship required.