Quebec, Quebec, Canada · Remote OK
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Clinical Trials, Site Activation, Regulatory Compliance, Good Clinical Practice, Investigator Initiation Package
Southport, North Carolina, United States · Remote OK
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Medical writing, Clinical documentation, Regulatory submissions, Project management, Clinical research
Taipei, Taiwan · On-site
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Clinical research, Site management, Protocol adherence, Data integrity, Regulatory compliance
Istanbul, Istanbul, Turkey · On-site
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Clinical research, Site management, Project management, Site start-up, Regulatory compliance
Hyderabad, Telangana, India · On-site
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Interpersonal Communication, Problem-solving, Analytical Thinking, Incident Management, Service Request Management
Bengaluru, Karnataka, India · On-site
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Prompt Engineering, Python, LLM Orchestration, LangChain, LangGraph
Hyderabad, Telangana, India · Remote OK
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: User Acceptance Testing, Vendor Management, Clinical Trial Operations, Project Management, Stakeholder Coordination
Bengaluru, Karnataka, India · On-site
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: AI System Architecture, Prompt Engineering, LLM Orchestration, AWS Bedrock, Python
Ciudad de México, Mexico · Remote OK
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Clinical trial monitoring, Site management, Regulatory compliance, Problem solving, Communication
Ho Chi Minh City, Vietnam · On-site
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Pharmacovigilance, Regulatory Compliance, ICSR Processing, Case Management, Literature Review
Manila, Metro Manila, Philippines · On-site
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Patient Safety, Clinical Development, Regulatory Compliance, Pharmacovigilance
Sydney, New South Wales, Australia · Remote OK
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Clinical Trial Monitoring, ICH/GCP, Site Management, Oncology, Regulatory Compliance
Argentina, Santiago del Estero, Argentina · Remote OK
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Clinical Trial Monitoring, Site Management, Regulatory Compliance, Problem Solving, Collaboration
Bengaluru, Karnataka, India · Remote OK
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: EU Clinical Trials Regulation (EU CTR), Regulatory Affairs, Team Leadership, Stakeholder Management, Regulatory Operations
Hyderabad, Telangana, India · Hybrid
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Site Activation, Regulatory Compliance, Clinical Trial Operations, ICH-GCP, Trial Master File (TMF)
Hyderabad, Telangana, India · On-site
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: CTIS Database, EU-CTR, Study Startup, Clinical Trial Operations, ICH-GCP
Romania · Remote OK
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Regulatory Affairs, Clinical Trial Applications (CTA), Submission Management, Project Strategy, Interpersonal Communication
Nunavut, Canada · Remote OK
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: R Programming, SQL, Real-World Data Analysis, Snowflake, Epidemiological Methodology
Mexico, Chihuahua, Mexico · Remote OK
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Regulatory Submissions, COFEPRIS Regulations, DIGIPRIS Platform, Technical Writing, Clinical Trial Management
Tokyo, Japan · Remote OK
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: CMC Regulatory Affairs, CTD Preparation, PMDA Consultation, Drug Master File (MF), Foreign Manufacturer Accreditation (FMA)
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The Site Activation Partner manages operational activities from study start-up to close-out to ensure compliance with clinical trial timelines and regulatory standards. They coordinate essential document management, support site initiation, and maintain clinical trial systems to track site performance.
Candidates must have at least 2 years of relevant experience in clinical trials and site activation within the pharmaceutical or CRO industry. A bachelor's degree in life sciences is preferred, along with strong knowledge of ICH/GCP, FDA, and global regulatory requirements.
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and sponsor standards. Other duties to include but not limited to:
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
Experience required for this role:
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
#LI-LO1
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our 22,000+ global employees work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™ We continue to earn recognition industrywide, including the 2025 Scrip Award for “Best Contract Research Organization – Full-Service Provider,” 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites Eagle Award. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
Offices: 541 Church at North Hills St, 1000, Raleigh, North Carolina 27609, US
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our 22,000+ global employees work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™ We continue to earn recognition industrywide, including the 2025 Scrip Award for “Best Contract Research Organization – Full-Service Provider,” 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites Eagle Award. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
Offices: 541 Church at North Hills St, 1000, Raleigh, North Carolina 27609, US
