Senior Clinical Site Manager

hace 3 semanas

Madrid, España Talent Source A tiempo completo

Description:
**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.

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a
- **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 high-performing 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 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.
- 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.
- 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 trial-related 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 investigator-facing 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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