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Study Start-Up Specialist – Site Activation Partner
ParexelSite Activation Partner at Parexel leading operational activities for clinical trials and site compliance. Collaborating with regulatory groups and managing investigator site issues.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trial activities, ensuring compliance with ICH/GCP and FDA regulations, and effectively coordinating site activation processes. Proficient in maintaining clinical trial systems and resolving site issues while collaborating with regulatory groups.
Highest-signal resume keywords
Clinical Trials ExperienceSite Activation ManagementICH/GCP KnowledgeRegulatory ComplianceBilingual Communication
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 Trial MethodologiesSite Compliance TrackingDocument ManagementIssue ResolutionProject Timeline Management
Soft Skills
CollaborationProblem-SolvingCommunication
Tools & Technologies
Clinical Trial Systems
Industry Keywords
Pharmaceutical IndustryCROFDA RegulationsLocal Country Regulations
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation
- Provide support to resolve issues or concerns and timely escalation of Site issues where applicable
- Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
- Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required
- Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
- Identify and resolve investigator site issues
Requirements
What you’ll need- School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred
- Minimum 2 years relevant experience in Clinical Trials environment and clinical site activation.
- Experience working in the pharmaceutical industry/or CRO is an asset
- Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
- Must be fluent in Local language and in English. Multi-language capability is an asset
Benefits
Comp & perks- Health insurance
- Professional development opportunities