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The Clinical Team Lead collaborates with the Directors of Clinical Operations to manage projects together with the clinical operations team, clinical monitoring team, Clinical Research Organizations (CROs) and other vendors. The Clinical Team Lead is responsible for the oversight of the clinical research associates (CRAs) and will regularly visit clinical trial investigators to monitor and oversee the quality of the trial data and develop relationships with Investigators and study staff. The Clinical Team Lead interacts and assists clinicians, clinical research coordinators and all other site clinical research personnel to ensure operational excellence and compliance with established regulations. The assigned clinical programs may include all stages of development (from Phase 1 to Phase 4) in the areas of Glaucoma, Dry Eye, and other ophthalmic conditions.

• Responsible for oversight of CRAs.
• Ensures that monitoring visits are conducted, and Monitoring Visit Reports are reviewed per the metrics outlined in the Monitoring Plan.
• Ensures that issues and action items from monitoring visits are addressed and closed in a sufficient manner and timeframe.
• Provides project-specific training for CRAs and may lead CRA meetings.
• Creates and implements study-specific clinical monitoring tools and documents.
• Performs site visits (alone or with CRAs).
• Assists in collection and assessment of trial documents.
• Attends study meetings with internal and external teams.
• Assures compliance with SOPs and local regulations, and CFR, ICH, and GCP guidelines.
• Contributes to authoring and/or review of Nicox SOPs.
• Supports oversight of CROs and other vendors.

• B.S. or B.A. or equivalent combination of education and experience. Masters preferred.
• Five (5) plus years of work experience for a pharmaceutical company or related field.
• Proficient understanding of ophthalmology studies and monitoring.
• Solid understanding of GCP, regulatory requirements and operational procedures.
• Excellent organization skills and ability to multi-task.
• Outstanding communication skills, both verbal and written.
• Proficient with Microsoft Office Word, Excel, and PowerPoint.
• Ability to work independently and prioritize duties.
• Experience working with cross-functional teams.
• Available to travel up to 50%.
• Valid driver’s license.

 To be successful in this role, the candidate needs to ensure the project meets the corporate goals on time. Top candidates are proficient multi-taskers with an ability to prioritize tasks.

The Clinical Team Lead collaborates with the Directors of Clinical Operations to manage projects together with the clinical operations team, clinical monitoring team, Clinical Research Organizations (CROs) and other vendors. The Clinical Team Lead is responsible for the oversight of the clinical research associates (CRAs) and will regularly visit clinical trial investigators to monitor and oversee the quality of the trial data and develop relationships with Investigators and study staff. The Clinical Team Lead interacts and assists clinicians, clinical research coordinators and all other site clinical research personnel to ensure operational excellence and compliance with established regulations. The assigned clinical programs may include all stages of development (from Phase 1 to Phase 4) in the areas of Glaucoma, Dry Eye, and other ophthalmic conditions.

• Responsible for oversight of CRAs.
• Ensures that monitoring visits are conducted, and Monitoring Visit Reports are reviewed per the metrics outlined in the Monitoring Plan.
• Ensures that issues and action items from monitoring visits are addressed and closed in a sufficient manner and timeframe.
• Provides project-specific training for CRAs and may lead CRA meetings.
• Creates and implements study-specific clinical monitoring tools and documents.
• Performs site visits (alone or with CRAs).
• Assists in collection and assessment of trial documents.
• Attends study meetings with internal and external teams.
• Assures compliance with SOPs and local regulations, and CFR, ICH, and GCP guidelines.
• Contributes to authoring and/or review of Nicox SOPs.
• Supports oversight of CROs and other vendors.

 

• B.S. or B.A. or equivalent combination of education and experience. Masters preferred.
• Five (5) plus years of work experience for a pharmaceutical company or related field.
• Proficient understanding of ophthalmology studies and monitoring.
• Solid understanding of GCP, regulatory requirements and operational procedures.
• Excellent organization skills and ability to multi-task.
• Outstanding communication skills, both verbal and written.
• Proficient with Microsoft Office Word, Excel, and PowerPoint.
• Ability to work independently and prioritize duties.
• Experience working with cross-functional teams.
• Available to travel up to 50%.
• Valid driver’s license.

 

To be successful in this role, the candidate needs to ensure the project meets the corporate goals on time. Top candidates are proficient multi-taskers with an ability to prioritize tasks.