Senior Clinical Site Manager

hace 4 semanas


En remoto, España Warman O'Brien A tiempo completo

Within this role, you will be responsible for the planning, initiation, coordination and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities to ensure compliance with SOPs, GCP and regulatory requirements. You will also engage with clinical sites to develop, build, and maintain strong relationships with investigators/staff that will ensure high quality investigative sites to support clinical development programs.

**Site Engagement Deliverables**:

- Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the Clinical Team and key internal stake holders throughout the life cycle of clinical trials
- Support clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles and using motivational tactics to ensure timely delivery of trials
- Engage, evaluate and develop a global network of high performing sites through coordinated, consistent interactions using multiple communication channels
- Develop & maintain relationships with site engagement organizations; assist in identification of high performing sites and key opinion leaders that can contribute to forums, boards and/or discussions
- Interact/train new investigators to work on clinical trials

**Monitoring Deliverables**:

- Responsible for all kinds of site visits (e.g. Selection / Initiation / Monitoring / Close-out / Motivational / Support) and sites’ performance regarding set-up, conduct and data collection Primary contact for sites regarding study-related issues.
- Responsible for the early engagement with Key Opinion Leaders (KOLs)/ sites / patients organizations and key contact point for these throughout the study.
- Interact/train new investigators to work on clinical trials.
- Attend key therapeutic trainings/meetings and/or industry trainings.
- Support CPM in management of the study
- Support the development of key study documents including, but not limited to Case Report Form (CRFs), diaries, informed consent/participant information, the study concept and protocols/amendments including presentations and Investigator Meetings or other trial related meetings.
- Prepare and/or review monitoring tools, e.g. monitoring manual
- Support CRO/vendor selection activities and provide input in development of contract specifications regarding monitoring activities for clinical trials.
- Review and approval of site regulatory packages
- Prepare or review responses to questions from Regulatory Authorities and IRBs/EC
- Conduct co-monitoring visits with internal or CRO personnel to ensure quality of trial and initiate corrective actions where appropriate

**Requirements of the role**:

- A minimum of 5 years of experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in site engagement or an investigator facing role (e.g. clinical project manager, study director/coordinator, clinical research associate, patient/site engagement companies)
- B.S., M.S. degree in a life science/biological related field preferred.
- At least three years experience in monitoring of trials in clinical development environment, preferably in phase II-IV
- Strong Knowledge of GCP and ICH Guideline
- Ability to supervise monitoring and related activities in a clinical trial.
- Ability to work without close supervision; ability to work under stress and within a team environment.
- Fluency in Spanish, English and one other European language
- Willingness to travel in Spain and abroad as required

**What you get in return**:

- A long-term contract with a global pharma
- A very competitive hourly rate

**Salary**: 80.00€ - 107.00€ per hour

Work Location: Remote

Application Deadline: 06/04/2023



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