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Clinical Engagement Specialist, Germany
vor 2 Monaten
JOB SUMMARY:
The Clinical Engagement Specialist plays a crucial role in facilitating communication and coordinating activities between clinical research sites and internal teams to ensure the successful execution of clinical assessments in line with project-specific requirements. The ideal candidate will deliver exceptional customer service and guarantee that all assessment-related tasks are completed promptly and meet client expectations.EDUCATION REQUIREMENTS:
A Bachelor's Degree in healthcare, life sciences, or a related discipline, or equivalent professional experience in the pharmaceutical or biotechnology sectors.QUALIFICATIONS/EXPERIENCE:
- A minimum of 2 years of experience in clinical research trials or a related field.
- Proven experience collaborating with sponsors and clinical sites, demonstrating successful management of clinical assessment projects is preferred.
- Experience with psychiatric indications (e.g., depression, anxiety) is advantageous.
- Basic understanding of the clinical trial process, Good Clinical Practices (GCP), FDA regulations, and relevant clinical terminology is essential.
- Familiarity with Institutional Review Board (IRB) regulations is a plus.
- Proficient in office management software, capable of managing databases, generating reports, and analyzing data.
- Experience with electronic Clinical Outcome Assessment (eCOA) platforms is beneficial.
- Technical skills to troubleshoot hardware, software, and network issues.
- Ability to work independently and collaboratively in a dynamic environment while managing multiple projects simultaneously.
- Strong organizational, prioritization, and time management skills.
- Excellent communication and problem-solving abilities.
ESSENTIAL DUTIES/RESPONSIBILITIES:
To excel in this role, the individual must effectively perform the following essential duties and responsibilities:- Collaborate with external stakeholders, including clinical research sites, and internal teams such as clinical science and clinician services to deliver services as specified in the scope of work for clinical assessments.
- Ensure adherence to company standards and expectations in clinician services, measured by visit availability, wait times, clinician utilization, and compliance with safety reporting.
- Manage multiple clinical trials concurrently, ensuring assessments are scheduled, initiated, and completed in accordance with study protocols.
- Provide administrative support for studies, including data entry, report generation, and database management.
- Foster positive relationships with study participants, healthcare professionals, and other stakeholders, offering basic technical support for hardware, software, and network issues as necessary.
- Develop project-specific manuals for the Assessment Solutions team as outlined in the study scope of work to ensure clarity in contracted services.
- Independently identify, resolve, and escalate issues to the appropriate internal team members.
- Assist in onboarding new clinical research sites through training, equipment testing, and mock assessments.
- Monitor query notifications and resolution processes with sites to maintain data integrity.
- Track subject visits and ensure compliance with risk reporting processes through report monitoring.
- Review protocols to support custom report generation for monitoring and tracking data captured in the clinical eCOA system.
- Develop and implement strategies to mitigate risks that could lead to deviations from study protocols.
- Alert Investigators/Sites, Clients, and the Clinical Science team when patient risks are reported, ensuring acknowledgment by both the Investigator/Site and Client.
- Assist in the development of site-facing IR documents and internal project plans specific to the Assessment Solutions services as detailed in the project scope.
- Perform other duties as assigned by the supervisor, which may occasionally be unrelated to the position.
- Attendance and punctuality are critical functions of this role.
TRAVEL REQUIREMENTS: Up to 5% based on business needs.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to perform sedentary work, which includes sitting for extended periods and occasionally lifting up to 25 lbs (11.3 kg). Further guidance on physical activities, requirements, visual acuity, and working conditions is available in HCM.
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