Updated: January 8, 2025
Location: United Kingdom-Europe - GBR-Home-Based
Job ID:24006584
*This job is only open to US and UK at this time.
JOB SUMMARY:
The Clinical Scientist will work collaboratively with the clinical lead and team to execute the clinical program(s). Their primary deliverable is to assist in planning, executing, and reporting of global clinical trials.
The clinical scientist also contributes beyond database release to support effective study reporting and close-out; submission activities; and audits/inspections, as appropriate.
JOB RESPONSIBILITIES:
* Maintain a thorough understanding of assigned protocols and protocol requirements.
* Contribute to communication of clinical study patient results internally and externally.
* Conduct activities related to data generation and validation, especially clinical data review.
* Generate additional data analysis based on TFLs in close collaboration with biostatistics.
* Analyze clinical study data, ensuring consistent quality data reviews, identifying clinical trends, reviewing, and summarizing scientific data.
* Author/review clinical study documents and clinical portions of regulatory documents.
* Participate in cross-functional teams and drive scientific evaluation and trial development activities.
* Contribute to authorship and review process for scientific publications and presentations.
* Transform scientific data into graphical presentations and demonstrate competence in Microsoft Office programs.
* Possess sound scientific and clinical understanding and experience in medical writing of study results and regulatory documents.
* Exhibit a very good command of biostatistics and ability to generate aggregated data overviews based on TFL data.
Possible Additional Responsibilities:
* Responsible for key elements of the planning, executing, and reporting of global clinical trials.
* Ensure clinical components of inspection readiness for all aspects of study conduct.
* Assist in ensuring regulatory compliance for clinical trials and reporting.
* Write standard protocols and amendments.
* Partner with study management to ensure that protocol and Monitoring Plan are consistently and appropriately implemented across investigator sites and countries.
* Ensure appropriate CRF design and high-quality data review plan in place; responsible for ongoing data review and signal detection during study execution.
* Proactively identify and resolve clinical-related issues as they arise.
Qualifications:
* Preferred: M.D., Ph.D., D.V.M., M.S., and/or PharmD., or equivalent qualifications.
* Minimum of 7 years total relevant experience (including biotech/pharmaceutical industry and academia), with at least 4 years in a biotech/pharmaceutical industry.
* Ability to transform scientific data into graphical presentations and demonstrate competence in Microsoft Office programs.
* Sound scientific and clinical understanding and experience in medical writing of study results and regulatory documents.
* Very good command of biostatistics and ability to generate aggregated data overviews based on TFL data.
* Knowledge and/or experience in rare diseases is a plus.
Demonstrated ability to support the conduct of clinical trials in industry, academic, or research clinic setting.
Demonstrated effectiveness in working in a multidisciplinary, matrix team situation.
Direct therapeutic area expertise may be required in some instances.
Understanding of scientific/clinical principles and ability to work across different therapeutic areas.
Ability to instill customer confidence in the ability to deliver project deliverables.
Extensive knowledge of the clinical development process including in-depth knowledge and understanding of the principles of GCP.
Ability to communicate effectively and appropriately with staff and investigator sites.
Knowledge of the clinical development process, understanding concepts of Phase II-IV and principles of study design. Experience in all phases of the clinical trial including study start, conduct, and reporting.
Ability to organize tasks, time, and priorities of self and others; ability to multi-task.
Risk management and contingency planning expertise required.
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization.
Ability to proactively communicate project issues and actions to mitigate risk and to ensure project members are aware of study status at all times.
At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Discover what our 29,000 employees already know: work here matters everywhere. We work hard and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.
Syneos Health is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies, and apply advanced business practices to speed our customers’ delivery of important therapies to patients.
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