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For one of our pharma clients we are looking for a combined function Study Start-Up Specialist - Country Study Specialist
Job description
The Study Start-up Specialist (SSUS) is responsible for all SSU-related activities in the country/region, on assigned studies, overseeing and leading SSU activities in collaboration with other clinical research stakeholders.
The Country Study Specialist (CSS) is responsible for providing project co-ordination and operational solutions to support Country Study Managers (CSMs). The position also provides clinical trial oversight to local study teams to enable effective management of both global and local trials.
According to an Affiliate's local resourcing situation, the responsibilities of this role can be covered by the CSM role.
Responsibilities
SSUS
• Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.
• Executes all start-up activities prior to site activation on assigned studies, according to client standards and aligned with study/project requirements and timelines
• Prepares country level Informed Consent Form (ICF) and obtains ethics committees' and local regulatory authorities' approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country.
• Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.
• Partners with Clinical Study Managers (CSMs) and Clinical Study Specialists (CSSs) to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations.
• Supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory/Quality department, as required.
• Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies/ laws, via innovative approaches.
• Submits, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SUSARs), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs).
• In collaboration with CSMs, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.
• Responsible for study budget and contracts negotiation in collaboration with Contracts Manager/Associate, as required and ensures compliance with Fair Market Value (FMV) in the country.
CSS
• Coordinates/supports operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring client quality and safety standards, regulations, timelines and budget commitments are met.
• Performs/coordinates protocol and site level feasibility activities, including evaluation of patient population and final site selection (if applicable).
• Provides input into and/or develops study related materials such as Monitoring Plans, Recruitment Plans and Study Newsletters.
• Supports/coordinates the negotiation of site budgets within Fair Market Value (FMV) guidelines, budget plans and provides oversight for site payments per contract, as required.
• Maintains effective and ongoing communication with CSM; supports communication with local study teams and to sites as required.
• Works with global study team and CSM to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of nonproductive sites and tracking of safety procedures.
• Supports management of country-level Trial Master File (TMF) and reviews for quality (including translations, as applicable).
• Is responsible for the co-ordination and oversight of local affiliate study level audit/ inspection audit action plan activities.
• Provides feedback to local vendor manager and CSM on CRAs, and local supplier/vendor performance.
• Coordinates study or country communication plan.
Requirements
• University Degree or equivalent, preferably in a medical/science-related field.
• Demonstrated knowledge and understanding of clinical trials and experience in managing projects.
• Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP), as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials in the relevant country.
• Previous line management experience/supervision of staff is preferred.
• Monitoring experience is required.
• Planning and Organizing - establishes an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines, and leveraging resources.
• Building Customer Loyalty - meets and exceeds internal or external customer expectations while cultivating relationships that secure commitment and trust
• Communication- conveys information and ideas clearly and concisely to individuals or groups in an engaging manner that helps them understand and retain the message; listens actively to others.
• Fluency in Dutch - French - English
Country Study Specialist / Study Start Up Specialist
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Location:
Anderlecht
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Contact:
Santina Fourneaux
-
Job type:
-
Contact phone:
0032 15 28 15 04
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Industry:
-
Contact email:
santina_fourneaux@oxfordcorp.com
Job description
The Study Start-up Specialist (SSUS) is responsible for all SSU-related activities in the country/region, on assigned studies, overseeing and leading SSU activities in collaboration with other clinical research stakeholders.
The Country Study Specialist (CSS) is responsible for providing project co-ordination and operational solutions to support Country Study Managers (CSMs). The position also provides clinical trial oversight to local study teams to enable effective management of both global and local trials.
According to an Affiliate's local resourcing situation, the responsibilities of this role can be covered by the CSM role.
Responsibilities
SSUS
• Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.
• Executes all start-up activities prior to site activation on assigned studies, according to client standards and aligned with study/project requirements and timelines
• Prepares country level Informed Consent Form (ICF) and obtains ethics committees' and local regulatory authorities' approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country.
• Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.
• Partners with Clinical Study Managers (CSMs) and Clinical Study Specialists (CSSs) to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations.
• Supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory/Quality department, as required.
• Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies/ laws, via innovative approaches.
• Submits, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SUSARs), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs).
• In collaboration with CSMs, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.
• Responsible for study budget and contracts negotiation in collaboration with Contracts Manager/Associate, as required and ensures compliance with Fair Market Value (FMV) in the country.
CSS
• Coordinates/supports operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring client quality and safety standards, regulations, timelines and budget commitments are met.
• Performs/coordinates protocol and site level feasibility activities, including evaluation of patient population and final site selection (if applicable).
• Provides input into and/or develops study related materials such as Monitoring Plans, Recruitment Plans and Study Newsletters.
• Supports/coordinates the negotiation of site budgets within Fair Market Value (FMV) guidelines, budget plans and provides oversight for site payments per contract, as required.
• Maintains effective and ongoing communication with CSM; supports communication with local study teams and to sites as required.
• Works with global study team and CSM to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of nonproductive sites and tracking of safety procedures.
• Supports management of country-level Trial Master File (TMF) and reviews for quality (including translations, as applicable).
• Is responsible for the co-ordination and oversight of local affiliate study level audit/ inspection audit action plan activities.
• Provides feedback to local vendor manager and CSM on CRAs, and local supplier/vendor performance.
• Coordinates study or country communication plan.
Requirements
• University Degree or equivalent, preferably in a medical/science-related field.
• Demonstrated knowledge and understanding of clinical trials and experience in managing projects.
• Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP), as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials in the relevant country.
• Previous line management experience/supervision of staff is preferred.
• Monitoring experience is required.
• Planning and Organizing - establishes an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines, and leveraging resources.
• Building Customer Loyalty - meets and exceeds internal or external customer expectations while cultivating relationships that secure commitment and trust
• Communication- conveys information and ideas clearly and concisely to individuals or groups in an engaging manner that helps them understand and retain the message; listens actively to others.
• Fluency in Dutch - French - English