Medical Operations Leader

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

Job Overview

The Senior Clinical Scientist (SCS) may lead or support a study or studies, depending on size/complexity. The SCS as lead is accountable for the clinical/scientific execution of the protocol.

Key Accountabilities:

Oversight/Leadership

• May lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol.

• As lead, will be responsible as the Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)

• Responsible for trial design and endpoint development in collaboration with CD

• Scientific lead on Clinical Trial Team (CTT)

Medical Monitoring

• Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports

• Monitors data issues requiring clinical input

• Monitors central lab reports and other external data for safety and critical values

• Prepares scientific slides, attends and presents protocol information at Investigator Meeting

• Participates in Database lock activities

• Reconciles and review all protocol deviation classifications in SPECTRUM

Clinical Trial Operational Delivery

• Sets up/supports SAC, DMC, adjudication committees

• Protocols/amendments – collaborates with medical writer, participates in governance committee review

• Authors protocol clarification letters

• Contributor to study specific documents (e.g., SMP)

• Reviews/updates informed consent

• Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs)

• Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation system

• Coordinates planning of lab, bio specimens and imaging specifications

• Co-authors newsletters with SM

• Collaboratively plans CSRs, CTDs/WMAs with medical writing

• Supports publications/presentations as needed

• Assesses and prepares protocol deviation list for CSR

• Collaborates with medical writing to develop trial results communication for investigators

• Provides scientific assessment for Operational Reviews

• Supports SM/MW activities as needed to achieve CTT deliverables.

• Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO)

• May act as mentor to other CSs

Compliance with Parexel Standards

• Complies with required training curriculum

• Completes timesheets accurately as required

• Submits expense reports as required

• Updates CV as required

• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• 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 .

Knowledge and Experience :

• Minimum 7 years with BS/BA or 5 years with MS/PhD pharmaceutical and/or clinical drug development (such as pharmaceutical/biopharma companies, hospital settings, research sites, clinical trial units, CRO, SMO) in the last 10 years required experience

• Minimum 2 years as a lead CS (phase I-IV clinical trials) with pharmaceutical / biotech / CRO company experience required (leads, monitors and supervises the tasks related to clinical trials) in the last 5 years.

• Minimum 2 years medical monitoring (proficient in reviewing patient data and resolving discrepancies in the following areas such as adverse events, trends of adverse events, end point management, labs) experience required

• TA-specific experience required for Oncology. TA specific experience preferred for IDV and GSM

• Indication specific experience preferred

Education:

• Degree in Life Sciences

• Bachelor of Science/Bachelor of Arts/Master of Science/PhD

#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.