Clin Ops Delivery Associate III

Thermo Fisher Scientific

. Coordinate, oversee, and complete assigned local trial activities according to the task matrix .

Posted 9/29/2026full-timeRomaniaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates strong organizational skills and attention to detail while managing multiple tasks efficiently. Proficient in maintaining study-specific documentation and ensuring compliance with applicable regulations and clinical practices.

Highest-signal resume keywords

Project CoordinationRegulatory Document ReviewClinical Trial Database SystemsMS Office ProficiencyInterpersonal Skills

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Document ProcessingData AnalysisETMF ReviewsRisk-Based MonitoringInvestigator Site File ManagementTranslation Quality ControlMeeting OrganizationProject Activity PlanningTask ManagementStudy Metrics Reconciliation

Soft Skills

Strong Organizational SkillsAttention to DetailCustomer FocusFlexibility and AdaptabilitySelf-Motivated

Tools & Technologies

GoBaltoETMF SystemClinical Trial Database Systems

Certifications & Qualifications

PPD Clinical Training Program

Industry Keywords

ICH Good Clinical PracticesCountry RegulationsSOPsWPDs

About the role

Key responsibilities & impact

Coordinate, oversee, and complete assigned local trial activities according to the task matrix
Perform department, internal, country, and investigator file reviews and document findings
Ensure allocated tasks are completed on time, within budget, and to high quality standards
Communicate project risks to project leads and line manager
Maintain study-specific documentation, team lists, training trackers, system access records, and project activity plans
Keep the electronic Trial Master File up to date and provide GoBalto and eTMF system support
Support risk-based monitoring activities
Process documents, perform eTMF reviews, conduct mass mailings, and provide reports to internal team members
Schedule and organize client or internal meetings and complete meeting minutes
Review and track local regulatory documents
Transmit documents to the client and centralized IRB/IEC
Analyze and reconcile study metrics and findings reports and assist with resolving site documentation findings
Maintain vendor trackers
Assist with compilation and distribution of Investigator Site File and Pharmacy binder materials and non-clinical study supplies
Assist with study-specific translation materials and translation quality control
Attend kick-off meetings and take notes when required
Act as an onboarding buddy and provide training to new staff as needed
Support departmental and cross-functional process improvement initiatives

Requirements

What you’ll need

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Bachelor's degree preferred
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 4 years
Combination of appropriate education, training and/or directly related experience may be considered as an equivalency
Ability to work in a team or independently as required
Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
Proven ability to analyze project-specific data/systems to ensure accuracy and efficiency
Strong customer focus
Flexibility and adaptability to reprioritize workload and meet changing project timelines
Ability to attain and maintain working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs
Excellent English language and grammar skills and proficient local language skills as needed
Good presentation skills
Excellent computer skills; proficiency in MS Office (Word, Excel, and PowerPoint) and ability to master clinical trial database systems
Ability to successfully complete PPD clinical training program
Self-motivated, positive attitude with effective strong interpersonal skills

Benefits

Comp & perks

Standard Monday-Friday work schedule
Hybrid work arrangement
Potential occasional travel