What are the responsibilities and job description for the Senior Clinical Scientist position at Parexel - USA?
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:
Primary Duties:
Interactive Voice Response System (IVRS), electronic Patient Reported Outcome (ePRO)]
Skills and Education:
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 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 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 beneficial
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