Director, Clinical Monitoring - Zug, Schweiz - Urovant Sciences GmbH
vor 4 Wochen
Beschreibung
Position Description:
Primary Responsibilities:
- The Director, Clinical Monitoring will be responsible for all aspects of monitoring and site management oversight for all of Urovant's CRO partners. He/she will work closely with Urovant's Clinical Operations Leads, Data Management, and QA, as well as with all involved functions and vendors (such as Contract Research Organizations [CROs]).
- She/he will act as the primary contact within Urovant for all aspects of monitoring and site management and will contribute to the preparation of study plans with the respective CROs, development and measurement of monitoring key performance indicators, ensuring delivery of quality operational results, and will be involved with the selection and oversight of applicable Clinical Operations vendors.
- She/he will be responsible to ensure consistency of process and approaches across global monitoring on all Urovant trials, and will work directly with the CRO monitoring organizations on ensuring quality monitoring deliverables through monitoring report review, observational visits, identification/mitigation of monitoring issues and compliance to study plans
- Working within the Clinical Operations organization, Director/Senior Director Global Clinical Monitoring will collaborate with Clinical Operations Leads, Clinical Development and/or Medical Affairs, Project Managers, and Finance on budgets related to monitoring oversight activities on assigned studies
- The Director/Senior Director Global Clinical Monitoring may mentor or supervise other employees or contractors within the Clinical Operations Team
- The Director/Senior Director Global Clinical Monitoring may develop/contribute to process development/improvement within Urovant in Clinical Operations, R&D, in Europe, as well as at the company level.
Education and Experience:
- Health or Biological Science degree required; BS or MS preferred.
- At least 10 years of experience in clinical monitoring, with at least 5 years of experience in global clinical trials, directly managing monitoring.
- Experience in monitoring all phases of clinical trials required.
- Previous experience at a sponsor/pharmaceutical company preferred.
Essential Skills and Abilities:
- Demonstrates leadership capabilities in cross functional teams.
- Good organizational skills.
- Good verbal and written communication skills.
- Good presentation skills.
- International travel required.
- Ability to work across locations and time zones.
- Ability to work on multiple projects and assignments at the same time.
- Ability to prioritize tasks.
- Strong financial business acumen and analytical skills.
- Strong interpersonal skills and ability to manage multiple vendors.
Mehr Jobs von Urovant Sciences GmbH
-
Sr Manager, Accounting and Reporting
Zug, Schweiz - vor 4 Wochen
-
Director, Strategic Finance
Zug, Schweiz - vor 4 Wochen
-
Executive Director, Heor
Zug, Schweiz - vor 4 Wochen