Clinical Research Scientist - I
About The Position
LeadStack Inc. is seeking a Clinical Scientist Consultant SME Level - Neurology for a 12-month, part-time (10 hours per week) remote position. The role involves supporting the planning and execution of neurology clinical programs, including CIDP. This includes reviewing various study documents, identifying risks and operational gaps, assessing strategies for study start-up, enrollment, monitoring, and participant retention. The consultant will also evaluate protocol operational feasibility, review clinical data and protocol deviations, assess site and vendor performance, and support the development of risk-mitigation plans. Collaboration with cross-functional teams and support for regulatory activities are key aspects of this role.
Requirements
- SME Level - Neurology
- Experience in supporting the planning and execution of clinical programs, specifically in neurology (e.g., CIDP).
- Ability to review and assess clinical trial operational documents (e.g., adjudication charters, endpoint assessment manuals, operational plans).
- Skill in identifying clinical trial execution risks, operational gaps, and barriers to enrollment, data quality, and study delivery.
- Experience in evaluating study start-up, site activation, enrollment, monitoring, vendor oversight, and participant retention strategies.
- Capability to assess protocol operational feasibility and support protocol development.
- Proficiency in reviewing clinical data, protocol deviations, and emerging study trends.
- Experience in evaluating site and vendor performance and understanding escalation pathways.
- Ability to support the development of risk-mitigation plans and issue-management processes.
- Strong cross-functional collaboration skills with various departments (Clinical Development, Clinical Operations, Biometrics, Regulatory, Safety) and external vendors.
- Experience supporting regulatory preparation and inspection/submission readiness.
Responsibilities
- Support the planning and execution of neurology clinical programs, including CIDP.
- Review of adjudication charters, endpoint assessment manuals, and related operational plans.
- Identification of clinical trial execution risks, operational gaps, and potential barriers to enrollment, data quality, and study delivery.
- Review of study start-up, site activation, enrollment, monitoring, vendor oversight, and participant-retention strategies.
- Assessment of protocol operational feasibility and support for protocol development and pivotal-study planning.
- Review of clinical data, protocol deviations, missing data, and emerging study trends to identify potential quality or execution concerns.
- Evaluation of site and vendor performance, including escalation pathways, roles and responsibilities, and operational accountability.
- Support for development of risk-mitigation plans, issue-management processes, and corrective and preventive actions, as appropriate.
- Cross-functional collaboration with Clinical Development, Clinical Operations, Biometrics, Regulatory, Safety, and external vendors.
- Support for regulatory preparation and inspection- or submission-readiness activities.
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What This Job Offers
Job Type
Part-time
Career Level
Senior
Education Level
No Education Listed
