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JOB SUMMARY: The Clinical Scientist supports assigned projects by interacting and communicating with investigative sites, study sponsors, and internal stakeholders to ensure quality and timely delivery of all clinical service offerings. The Clinical Scientist represents WCG scientific expertise at all external meetings. The Clinical Scientist co-leads all assigned projects with Project Management and collaborates cross-departmentally to ensure the success of the project.
EDUCATION REQUIREMENTS:
- Graduate degree in a life science discipline or other field relevant to the business focus preferred.
- Bachelor's degree required.
QUALIFICATIONS/EXPERIENCE:
- Five years of experience in the clinical research industry required; experience working for a biopharmaceutical sponsor or a clinical research organization preferred.
- Minimum 3 years of experience as a clinical scientist, clinical trial science lead, clinical site educator/supervisor or similar role with client-facing scientific responsibilities.
- Minimum 4 years of experience with the administration and/or training of rating scales with practical knowledge of study endpoints as part of sponsored clinical research is required.
- Ability to function effectively in a fast-paced environment and manage multiple projects simultaneously.
- Ability to lead through influencing and negotiating; demonstrated leadership skills and ability to integrate in a team, motivate others and communicate clearly and effectively.
- Strong problem solving/decision making skills, demonstrated by ability for independent critical thinking, solution generation and engagement in active scientific exchange.
- Solid understanding of basic and intermediate research methods and statistics.
- Strong communication and negotiation skills across audiences with a demonstrated ability to assess complex situations and devise impact-generating solutions based on incomplete data.
- Demonstrated ability to present in front of large audiences from varied backgrounds requiring the ability to tailor the discussion to meet their needs.
- Fluent in English; bi-lingual or multi-lingual skills are preferred.
- Strong understanding of Good Clinical Practice (GCP).
ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.
- External facing clinical representative responsible for the independent clinical management of international clinical trials.
- Own scientific responsibility and co-lead each assigned project, along with accountability for ensuring that the scientific integrity is maintained and all necessary analyses and remediations are conducted and effectively communicated.
- Actively participate in internal and external project meetings (e.g., weekly external client call, Investigators' meetings).
- Review, monitor, and proactively address issues regarding study level metrics; present study dashboards to sponsors by reviewing data, any outliers or areas of concern, as well as any actions taken to address these concerns.
- Resolve clinical quality or training related issues.
- Responsible for the calibration of clinical team, conduct rater training events, and remediations as specified in the study-specific training plans.
- Provide scientific support to external and internal stakeholders, leveraging strong communication and negotiation skills and strategies.
- Respond to and resolve external inquiries regarding WCG scoring or feedback.
- Communicate with all internal stakeholders and coordinate resources to meet project objectives.
- Assist with or take responsibility for the development of project deliverables (e.g., scale verification, electronic form development, training materials for in-person or online training, etc.).
- Work with Business Development to review potential studies, RFPs, as needed.
- Develop and nourish peer-to-peer relationships with external consultants, key opinion leaders, and clinicians, both regionally and in research areas of interest.
- Actively participate in research and publication efforts and report research results externally through peer-reviewed journals, conferences, or other appropriate venues.
- Identify the need for and contribute to the development of departmental and cross-disciplinarywork instructions, process guidelines and standard operating procedures to ensure all processes and procedures meet SOP/GCP requirements.
- Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
- Proficient knowledge of MS Office, specifically Word, Excel, PowerPoint and the ability to produce detailed reports and presentations using these tools.
- Attendance and punctuality are essential functions of the position.
- Ability to provide documentation allowing international travel.
TRAVEL REQUIREMENTS: This role may require up to 20% travel which may be domestic or international, including overnight and weekend stays, consistent with project needs and office location.
EXPECTED ANNUAL BASE SALARY: $87,480 to $136,000
GPS LEVEL: P4
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WIRB - Copernicus Group
Oct 13, 2023