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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical study support, including data reconciliation, protocol deviation management, and stakeholder interaction. Proficient in ICH-GCP compliance and possesses a strong foundation in Life Sciences.
Highest-signal resume keywords
Clinical Drug Development ExperienceICH-GCP ComplianceData Review and ResolutionMicrosoft Office ProficiencyLife Sciences Degree
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study SupportData ReconciliationProtocol Deviation ManagementAdverse Event ReviewEndpoint Management
Soft Skills
Oral Communication SkillsWritten Communication Skills
Tools & Technologies
Microsoft OfficeOneNote
Industry Keywords
Pharmaceutical ExperienceOncologyClinical StudiesMedical MonitoringStudy Site Interaction
About the role
Key responsibilities & impact- Assist the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies
- Support adjudication, medical monitoring, imaging data reconciliation, preparation of meeting materials, and protocol deviation management
- Support a single study or multiple studies
- Lead a study with limited scope, such as Survival Follow-up
- Interact with internal and external stakeholders, including study sites and committees, in support of clinical study objectives
- Complete required training curriculum
- Complete timesheets accurately and on time
- Submit expense reports as required
- Update CV as required
- Maintain working knowledge of and comply with Parexel processes, ICH-GCPs, and other applicable requirements
Requirements
What you’ll need- At least 2 years Pharmaceutical and/or clinical drug development experience in the last 5 years required
- TA-specific experience required for postings in Oncology IDV and GSM preferred
- Indication specific experience preferred
- Experience reviewing and resolving study related data issues, including issued queries, resolved queries, medical record review, and identifying data errors requiring clarification with study sites
- Proficient in reviewing patient data and resolving discrepancies involving adverse events, adverse-event trends, endpoint management, and labs experience preferred
- Demonstrated oral and written communication skills
- Proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required
- OneNote experience preferred
- Degree in Life Sciences
- Bachelor of Science, Bachelor of Arts, Master of Science, or PhD
