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Senior Clinical Scientist - SCS (CSSM)

Parexel International Corporation

Multiple Locations

Parexel FSP is looking for Senior Clinical Scientists- Remote position- anywhere in the US and Canada!!

Job Title: Senior Clinical Scientist (SCS)

Position Purpose: 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.

Organizational Relationships:

• Reports to ExecuPharm (EP) assigned Line Manager with day-to-day direction from Client

 • Liaises with cross-functional lines as appropriate

Primary Duties:

• Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., Institutional Review Board (IRB), sites)

 • Responsible for trial design and endpoint development in collaboration with Clinical Director (CD)

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

• Sets up/supports SAC (Scientific Advisory Committee), DMC (Data Monitoring Committee), adjudication committees • Protocols/amendments – collaborates with medical writer, participates in governance committee review • Authors protocol clarification letters

 • Contributor to study specific documents [e.g., Study Monitoring Plan (SMP)]

• Reviews/updates informed consent • Provides scientific input to Study Manager (SM) for data management activities (e.g., Electronic Data Capture, Data Review Plan, Case Report Forms)

 • 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

• Scientific lead on Clinical Trial Team (CTT)

• 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

 • Participates in Database lock activities

• Collaboratively plans CSRs (Clinical Study Reports), CTDs (Common Technical Documents)/WMAs (Worldwide Marketing Authorization) with medical writing

 • Supports publications/presentations as needed

 • Reconciles and review all protocol deviation classifications in SMART

 • Assesses and prepares protocol deviation list for CSR

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

• Provides scientific assessment forOperational Reviews

• Supports Study Management/Medical Writing activities as needed to achieve CTT deliverables

 • Provides clinical specifications to SM to support interactions with external vendors [e.g., Interactive Voice Response System (IVRS), electronic Patient Reported Outcome (ePRO)]

• May act as mentor to other Clinical Scientists (CSs)

• Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training

• Adhere to EP and Client SOPs and processes

Skills and Education:

 • BS/BA in Life Sciences with 7+ years clinical research experience

• MS/PhD in Life Sciences with 5+ years clinical research experience

 • If no degree in Life Sciences, must have significant experience in clinical development (>11 years)

• Minimum 2 years pharmaceutical experience with demonstrated leadership responsibilities required. • Medical monitoring experience required

• Excellent Excel and PowerPoint (PP) skills required

• Excellent written and oral communication skills

 • Therapeutic Area (TA) specific experience ben

#LI-REMOTE

Job posted: 2022-09-27

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