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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical project coordination, including study set-up, regulatory documentation, and stakeholder communication. Proficient in managing complex projects with strong attention to detail and a customer-oriented mindset.
Highest-signal resume keywords
Clinical Project CoordinationStudy Start-Up ExperienceRegulatory Documentation SubmissionMicrosoft Office ProficiencyExperience in Cancer Research
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 ResearchData ProgrammingStatistical AnalysisAssay PrinciplesImmunohistochemistryGenomicsHistopathologyGCP ComplianceCAP/CLIA Standards
Soft Skills
Professional-Level CommunicationStrong Attention to DetailCritical ThinkingProblem-SolvingAdaptability
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Power BI
Industry Keywords
Clinical TrialsIn Vitro DiagnosticsEMEA GuidelinesFDA GuidelinesLaboratory Operations
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Deliver clinical projects within agreed scope, timeline, and budget by coordinating internal and external partners
- Coordinate clinical study set-up activities from project award through study initiation and operational readiness
- Work alongside experienced Project Managers to learn project management methodologies and assume increasing responsibilities
- Identify customer needs and maintain projects on task, on track, and on time
- Initiate study set-up by engaging Business Development colleagues and/or clients
- Draft and develop analytical plans with clients and internal teams
- Gather study requirements and translate them into set-up activities, timelines, documentation, and internal deliverables
- Coordinate with internal stakeholders to ensure Operations is prepared to initiate study testing
- Initiate database builds when required and ensure timely commencement
- Support preparation and submission of regulatory documentation to ethics committees and regulatory authorities
- Coordinate and host client kick-off meetings
- Manage scope changes during contracting and study set-up under appropriate supervision
- Maintain comprehensive study set-up documentation, centralized project communications, and meeting minutes
- Identify and escalate risks, issues, dependencies, and roadblocks
- Provide clear study set-up updates to internal and external stakeholders
- Coordinate an organized handoff to the Conduct Project Manager upon completion of set-up
Requirements
What you’ll need- A Master’s degree in Sciences, Biomedical Sciences, Pharmaceutical Sciences, Medical Biology, Pharmaceutical Sciences, Medicine, or equivalent expertise gained through experience
- 1 to 2 years of project coordination, project management, clinical research, laboratory, or related project support experience
- Study Start-up experience is a plus
- Great curiosity and learning appetite, with a humble and teachable spirit
- Positive and energetic attitude
- Proven success in managing complex projects to completion
- 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 and ability to multitask
- Self-motivated, adaptable, and able to thrive in a dynamic environment
- Strong attention to detail
- Ability to work independently and collaboratively
- Strong critical thinking and problem-solving abilities
- Customer- and project service-oriented mindset
- Solution-driven attitude with persistence and determination
- Experience in cancer research is preferred
- Understanding of clinical laboratories, assay/instrument principles involved in in vitro diagnostic product design and use, and scientific, statistical, regulatory, and compliance requirements of clinical research is preferred
- Experience working in or with Histopathology and/or Genomics services is preferred
- Experience working in CAP, CLIA, and GCP environments, with working knowledge of EMEA and/or FDA guidelines related to clinical trials is preferred
- Experience with histopathology, anatomic pathology, immunohistochemistry (IHC), genomics, FISH, ISH, or immunofluorescence is preferred
- Experience in data programming and validation is preferred
- Experience working in global settings is preferred
Benefits
Comp & perks- 9 additional CellCarta Days (prorated based on full-time or part-time status)
- Meal vouchers (€8 per working day)
- Net allowance
- DKV hospitalization insurance
- Group insurance plan with employer contributions
- Bike leasing after six months of service
- Public transportation reimbursement or bicycle/car allowance
- Career advancement opportunities