Zurück zur Suche.Stamford Consultants - English - International Clinical Trial Manager
| Beschäftigungstyp: | Contract |
| Standort: | Basel - Basel-Stadt, Switzerland, 4056 |
| Gehalt: | 9'000 CHF |
| Sprachen: | Englisch |
| Erforderlichen Sprachen: | 1 |
Details für die Anzeigenschaltung
- Name:Stamford Consultants
- Veröffentlichung:13-02-2012
- Code:VR/03586
Task
- Responsible and/or Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
- Responsible to identify and update operational tracking tools, including systems to meet the needs of the operations team and ensures reporting to the GTAL.
- Develops and manages clinical study budgets. Communicates variances in the budget and action plan for resolution to the GTAL. Establishes study milestones and ensures accurate tracking and reporting of study metrics.
- Provides clinical operations expertise to ensure operational feasibility and delivery
- Develops the site feasibility questionnaires and creates the study level patient recruitment plan and retention strategies based on feasibility data and input from the CRO and affiliate and consultation with the GTAL and GCOGL.
- Analyzes the feasibility data across countries with input from the affiliates and provides the strategic country and site distribution and patient numbers to the GTAL.
- Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes.
- Oversees forecasting of clinical/non-clinical supplies
- Designs drug assumption and supply chain process in partnership with Drug Supply Coordinator, affiliates and GTAL.
- Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study.
- Delivers the operational elements of the study plan
- Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings (depending on competency level).
- Ensures that safety reporting is established and maintained for the duration of the study and that reporting timelines are met.
- Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GTAL and implements contingencies in consultation with the GTAL.
- Primary contact with CRO and affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action.
- Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits.
- Oversees the maintenance of drug supplies and resolution of issues with input from Clinical Drug Supply coordinator.
- Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs.
- Provides operational input into the development and tracking of SMT goals.
Profile
- Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment.
- 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, budgets and resource plans.
- 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 ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the
organization
- Responsible and/or Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
- Responsible to identify and update operational tracking tools, including systems to meet the needs of the operations team and ensures reporting to the GTAL.
- Develops and manages clinical study budgets. Communicates variances in the budget and action plan for resolution to the GTAL. Establishes study milestones and ensures accurate tracking and reporting of study metrics.
- Provides clinical operations expertise to ensure operational feasibility and delivery
- Develops the site feasibility questionnaires and creates the study level patient recruitment plan and retention strategies based on feasibility data and input from the CRO and affiliate and consultation with the GTAL and GCOGL.
- Analyzes the feasibility data across countries with input from the affiliates and provides the strategic country and site distribution and patient numbers to the GTAL.
- Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes.
- Oversees forecasting of clinical/non-clinical supplies
- Designs drug assumption and supply chain process in partnership with Drug Supply Coordinator, affiliates and GTAL.
- Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study.
- Delivers the operational elements of the study plan
- Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings (depending on competency level).
- Ensures that safety reporting is established and maintained for the duration of the study and that reporting timelines are met.
- Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GTAL and implements contingencies in consultation with the GTAL.
- Primary contact with CRO and affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action.
- Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits.
- Oversees the maintenance of drug supplies and resolution of issues with input from Clinical Drug Supply coordinator.
- Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs.
- Provides operational input into the development and tracking of SMT goals.
Profile
- Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment.
- 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, budgets and resource plans.
- 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 ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the
organization
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