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Job Description & How to Apply Below
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
Position Requirements
10+ Years
work experience
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