For one of our clients, located in Lisbon (Portugal), we currently have 2 projects available within the area of Clinical Country Study Management. One project is for 9 months, the second > 12 months. Previous experience as a Study Manager or Lead CRA is required.
The Clinical Study Manager (CSM) provides leadership to one or more Local Study Teams (LSTs) and provides local strategic planning and organization to achieve successful study completion. The CSM maintains full ownership of the Affiliate portion of a study and ensures the effective and efficient delivery of country/region operational aspects in accordance with the study development plan and ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements. The CSM also ensures the development and maintenance of productive relationships with our customers.
Provides Direction and Leadership to one or more LSTs:
- Sets the LST goals and ensures goals are in line with the operational strategy. Provides coaching to the team to facilitate the setting and achievement of goals
- Ensures that each team member is aware of his/her specific area of accountability and responsibility within the LST
- Manages and coaches performance of study team members by setting expectations, supporting team members, monitoring performance, providing feedback and following up, when appropriate to ensure performance is optimized
- Liaises with other functional groups to ensure the LST(s) members and monitors receive appropriate therapeutic area and study specific training
Establishes Study Timelines, Budget, Resource, Risk and Quality Plans:
- Oversees project, protocol and site feasibility and determines site selection and patient allocation (total and annualized) within the Affiliate
- Analyzes results of project, protocol and site feasibility testing, and provides country feedback or recommendations to SMT
- Responsible for ensuring site level contracts are completed
- Provides input from a country/region perspective into development and implementation of drug management, contracts, budgeting, resourcing, source document verification, data flow, case report forms, and safety monitoring for the Affiliate
Manages the Delivery of Study Activities in Order to Meet Study Plans
- Design and implement a country level training plan to ensure that team members and investigators receive training on the protocol, ICH-GCP requirements, and applicable process/procedures
- Ensures protocol adherence and consistency of study processes and procedures across all Affiliate investigational sites
- Ensures patient safety and data quality maintained, and that any concerns are escalated appropriately
- Ensures monitoring reports are timely, reviewed and takes appropriate actions for follow up on site issues
- Ensures that data is delivered in accordance with established dataflow timelines
- Ensures that trial management tracking tools (e.g. CTMS/SDE) and systems are populated and maintained
- Leads and or organizes (or assists in organizing) and/or participates in local or regional meetings and training sessions (i.e., LST meetings, Investigator Meetings, Monitor's Workshops, and CRO training.)
- Oversees the management of the local affiliate studies budget
Identifies Areas of Best Practice and Process Improvements
- Leadership: developed through leading multi-functional matrix study teams through all stages of clinical studies
- Project Management: including implementation of risk management plans and management of complex study budgets and resourcing plans
- Communication: excellent written and verbal communication skills demonstrated by the ability to present clear messages from complex information/data to all levels in the organization
- Personal Organization: demonstrated ability to prioritize and manage multiple tasks, self-motivated and achievement driven.
- Good knowledge of ICH GCP, GPP, SOPs/Guidelines and quality standards related to study management.
- Clear and accurate communication in written and spoken English and Portuguese.
- Demonstrated ability to interact with different professional levels of the research community
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 16595