Senior Clinical Scientist - FSP

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 

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