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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical studies from initiation to close-out, ensuring compliance with GCP guidelines and CellCarta’s Quality System. Proficient in project management, client communication, and coordination of cross-functional teams to deliver projects on time and within budget.
Highest-signal resume keywords
Project ManagementClinical Research Associate (CRA) ExperienceGCP ComplianceMicrosoft Office ProficiencyClient-Facing Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project ManagementClinical ResearchBioanalytical ReportingData ProgrammingBudget MonitoringStudy CoordinationAssay PrinciplesClinical Research RequirementsAttention to DetailProblem-Solving
Soft Skills
Professional CommunicationOrganizational SkillsAdaptabilityCritical ThinkingCustomer-Focused Mindset
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Power BI
Industry Keywords
GCPCAPCLIAEMEA GuidelinesFDA GuidelinesCancer ResearchHistopathologyGenomics Services
About the role
Key responsibilities & impact- Support management of clinical studies from initiation through close-out
- Drive and manage projects with internal stakeholders and external pharma and biotech customers
- Deliver clinical projects within agreed scope, time, and budget
- Coordinate tasks performed by internal and external partners
- Ensure projects comply with CellCarta’s Quality System
- Work with experienced Project Managers to learn methodologies and progressively assume responsibilities
- Manage global clinical studies from completed setup through close-out and archiving
- Prepare bioanalytical reports in compliance with GCP guidelines and regulations
- Coordinate and lead recurrent and ad hoc sponsor calls
- Assist with governance-level sponsor meetings as assigned
- Schedule sample testing and monitor study progress
- Oversee result reporting to sites and sponsors and ensure agreed turnaround times
- Monitor study budgets, prepare sponsor invoices, and project future revenue by study
- Maintain professional communication with sponsors, cross-functional project teams, and management
- Initiate and monitor close-out activities, including final invoicing and archiving
Requirements
What you’ll need- Bachelor’s degree in Biology, Biochemistry, Biomedical Sciences, Pharmaceutical Sciences, or Medicine
- 1-2 years of project management and/or CRA (Clinical Research Associate) experience and/or related project management support responsibilities
- Multiple years of experience in a client-facing role
- Proven success in managing complex projects to completion, with positive feedback and the ability to balance multiple priorities effectively
- Professional-level communication skills; proficient in English, both written and verbal
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Power BI)
- Excellent organizational skills with the ability to multitask
- Positive and energetic attitude
- Self-motivated, adaptable, and able to thrive in a dynamic environment
- Diligent with strong attention to detail
- Capable of working both independently and collaboratively
- Strong critical thinking and problem-solving abilities
- Customer- and project-focused mindset
- A solution-driven attitude with persistence and determination
- Master’s degree in Biology, Biochemistry, Biomedical Sciences, Pharmaceutical Sciences, or Medicine preferred
- Experience in cancer research and understanding of clinical laboratories, assay/instrument principles, and clinical research requirements preferred
- Experience working in or with Histopathology and/or Genomics services preferred
- Experience working in CAP, CLIA, and GCP environments, with working knowledge of EMEA and/or FDA guidelines related to clinical trials preferred
- Experience in data programming and validation preferred
- Experience working in global settings preferred
- Availability Monday-Friday, 8:00 a.m.-5:00 p.m., with flexibility
- Legally authorized to work in the U.S.
- Must disclose whether employment-based visa sponsorship is required
Benefits
Comp & perks- Medical, dental, and vision benefits
- Telemedicine service and Employee Assistance Program (EAP)
- Vacation and sick time
- 401(k) Retirement Savings Plan with employer matching
- Employee Annual Incentive Plan (EAIP)
- Career development opportunities
- Certifications Support Program
- Life insurance
- Short-term and long-term disability
- Hybrid flexibility to work from home, starting with approximately 1-2 days per week and gradually increasing following the training period
