Senior Clinical Scientist

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 Parexel 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 for Operational 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 Parexel, 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 beneficial