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Senior Clinical Site Manager
hace 1 semana
Location:
Barcelona, Madrid, Spain
- home based
Schedule:
Freelance - 1 FTE
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it is the best of both worlds.
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Senior Clinical Site Manager, to join our client-based team at one of the leading global biopharmaceutical companies. Our client is a world leader, mainly working in the fields of neurology and immunology. Working with both scientists and academics across the globe, they have a focus on new products and a strong science-based approach.
The Senior Clinical Site Manager is responsible for the planning, initiation, coordination, and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities for Rare Disease studies.
They will engage with clinical sites to develop, build, and maintain strong relationships with investigators/staff to ensure high-quality investigative sites to support clinical development programs.
Main Job Tasks and Responsibilities:
- Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the Clinical Team and key internal stakeholders throughout the life cycle of clinical trials.
- Supports the clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles, and using motivational tactics to ensure the timely delivery of trials.
- Engages, evaluate, and develop a global network of highperforming sites through coordinated, consistent interactions using multiple communication channels to create awareness of the activities of the client.
- Develops and maintains relationships with site engagement organizations; assist in the identification of highperforming sites and Key Opinion Leaders that can contribute to forums, boards, and/or discussions.
- Interact/train new investigators to work on clinical trials.
- Responsible for all kinds of site visits (e.g., Selection / Initiation / Monitoring / Closeout / Motivational / Support) and sites' performance regarding setup, conduct and data collection.
- Primary contact for sites regarding studyrelated issues.
- Maintain early engagement with Key Opinion Leaders /sites/patients organizations and key contacts throughout the study.
- Supports in the management of the study, including but not limited to vendor management, training, logistics, selection of sites, maintenance of study trackers, and oversight of eTMF.
- Close cooperation with the Clinical Project Managers and members of the Clinical Trial Teams to inform on all aspects of the clinical trial status at the site.
- Ensure appropriate engagement and communication with internal stakeholders regarding site visits and related activities.
- Support the development of key study documents including, but not limited to Case Report Forms (CRFs), diaries, informed consent/participant information, the study concept, and protocols/amendments including presentations and Investigator Meetings or other trialrelated meetings.
- Prepare and review monitoring tools, e.g., monitoring manual.
- Support CRO and vendor selection activities and provide input in the development of contract specifications regarding monitoring activities for clinical trials.
- Review and approve of site regulatory packages.
- Prepare or review responses to questions from Regulatory Authorities and IRBs/ECs.
- Contribute to updates of clinical program information, e.g., annual safety updates, Investigator's Brochure, and query resolution, as needed, etc.
Education and Experience:
- Extensive experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference for individuals who have experience in site engagement or an investigatorfacing role (e.g., Coordinator, Clinical Research Associate, patient/site engagement roles)
- B.S. or M.S. degree in a life science/biological related field preferred.
- Proven experience monitoring trials in the clinical development environment, preferably in phases II-IV.
Specific Role Requirements and Skills:
- Previous experience with Rare Disease studies would be beneficial.
- Strong Knowledge of GCP and ICH Guidelines
- Strong facilitation skills
- Good collaborator
- Clear and articulate verbal, written, and presentation skills with excellent command of English and/or local language
- Excellent verbal and written communication
- Ability to operate effectively within an international and rapidly changing environment
- 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
- Proficient in MS Office Suite
- Curious and agile, "nothing is impossible" mentality
- Abi
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