Senior Clinical Scientist – Medical Operations Lead

Parexel; Atlanta (GA); Remote; USD 140,000 - 190,000; Full time

Job summary

Parexel is seeking a Senior Clinical Scientist in the United States to lead or support clinical studies, ensuring rigorous scientific execution of protocols. You will serve as the clinical point of contact for scientific issues with stakeholders and collaborate on trial design and endpoints with the clinical design team.

As part of the Clinical Trial Team, you will lead Medical Monitoring activities, prepare presentation materials, support CSRs and publications, and mentor junior CSs as needed.

Qualifications

• Experience reviewing and resolving study related data issues such as issued queries, resolved queries, accurate review of medical records, identify any errors in data by performing data review that require further clarification with the study sites, etc. required
• Demonstrated oral and written communication skills
• Proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required. One Note experience preferred.
• Motivate their team, handle and delegate responsibilities, listen to feedback and remain flexible .

Responsibilities

• Lead or support a study or studies; accountable for protocol execution.
• Serve as clinical point of contact for scientific issues for internal and external stakeholders.
• Responsible for trial design and endpoint development with CD.
• Scientific lead on Clinical Trial Team (CTT).
• Lead Medical Monitoring; develop MMP and review SAE reports.
• Monitor data issues requiring clinical input.
• Review central lab reports and external data for safety.
• Prepare scientific slides and present at Investigator Meetings.
• Participate in database lock activities.
• Reconcile and review protocol deviation classifications in SPECTRUM.
• Set up/support SAC, DMC, adjudication committees.
• Collaborate on protocols/amendments with medical writer.
• Authors protocol clarification letters.
• Contribute to study documents (SMP).
• Review/update informed consent.
• Provide scientific input to SM for data management (EDC, DRP, CRFs).
• Review specs and allocation schedule generation system.
• Coordinate planning of lab, biospecimens and imaging specs.
• Co-authors newsletters with SM.
• Collaboratively plan CSRs, CTDs/WMAs with medical writing.
• Support publications/presentations as needed.
• Assess protocol deviation lists for CSR.
• Collaborate with medical writing to develop trial results communication.
• Provide scientific assessment for Operational Reviews.
• Support SM/MW activities to achieve CTT deliverables.
• Provide clinical specs to SM for interactions with external vendors (IVRS, ePRO).
• May act as mentor to other CSs.

Skills

Data issue review

Oral & written communication

MS Office proficiency

Team leadership & delegation

Education

BS/BA in Life Sciences

MS/PhD in Life Sciences

Tools

Microsoft Office

OneNote

Job description

Parexel is seeking a Senior Clinical Scientist in the United States to lead or support clinical studies, ensuring rigorous scientific execution of protocols. You will serve as the clinical point of contact for scientific issues with stakeholders and collaborate on trial design and endpoints with the clinical design team.

As part of the Clinical Trial Team, you will lead Medical Monitoring activities, prepare presentation materials, support CSRs and publications, and mentor junior CSs as needed.