Our client, a world
leader in biotechnology and life sciences, is looking for a “Clinical
Scientist Consultant / Neurology SME (100% Remote)” – Part time.
Job Duration: Long
Term Contract (Possibility Of Extension)
Pay Rate : $103/hr on
W2
Company Benefits: Medical, Paid Sick
leave, 401K
We are seeking a Clinical
Scientist Consultant / Neurology SME to provide scientific and clinical
expertise supporting the planning and execution of pivotal neurology clinical
programs.
Key Responsibilities
- Provide clinical SME guidance for neurology clinical trials, including
pivotal studies.
- Review
and provide input on protocols, endpoints, adjudication charters,
endpoint assessment manuals, and clinical study plans.
- Identify
clinical trial risks, operational gaps, enrollment challenges,
data-quality concerns, and protocol issues and recommend mitigation
strategies.
- Assess site performance, patient enrollment/retention, monitoring, vendor
oversight, and overall study execution.
- Review
clinical trial data, including protocol deviations, missing data,
emerging trends, and data-quality issues.
- Partner
cross-functionally with Clinical Development, Clinical Operations,
Biometrics, Regulatory, Safety, and external vendors.
- Support pivotal-study and regulatory readiness activities.
Required Qualifications
- Strong
experience in neurology clinical trials, preferably pivotal Phase
2/3 studies.
- Senior-level
experience as a Clinical Scientist, Clinical Development
Scientist/Lead, or similar clinical development role.
- Hands-on
experience with protocol development/review, clinical endpoints, and
clinical trial data.
- Ability
to assess study risks and provide scientifically sound recommendations
and mitigation strategies.
- Understanding
of clinical trial operations, including sites, enrollment, monitoring,
vendors, and data quality.
Preferred
- CIDP
(Chronic Inflammatory Demyelinating Polyneuropathy) or related
neuromuscular/neurology experience.
- Experience
with endpoint adjudication.
- Regulatory
submission/readiness experience.
- Experience
supporting cross-functional pivotal clinical programs.
If interested, please
send us your updated resume at
hr@dawarconsulting.com
/
akansha@dawarconsulting.com