Parexel hiring Site Start-Up Specialists

Parexel Site Start-Up Specialist Recruitment 2026 | Clinical Trials Jobs in Hyderabad | Apply Online Looking for Parexel jobs in Hyderabad, Clinical Trials jobs, or Site Start-Up Specialist vacancies Heres an excellent opportunity to join one of the worlds leading Clinical Research Organizations (CROs). Parexel is hiring a Site Start-Up Specialist for its Hyderabad office. Candidates with a Bachelors degree and 12 years of relevant clinical research experience are invited to apply. Professionals with knowledge of ICH-GCP, Trial Master File (TMF), regulatory documentation, and site activation will find this role particularly rewarding. Company Overview Parexel is a leading global Contract Research Organization (CRO) that partners with biopharmaceutical, biotechnology, and medical device companies to accelerate the development of innovative medicines. With operations in more than 100 countries, Parexel supports every phase of clinical development, from early-stage research to regulatory approval. The company is recognized for its expertise in Clinical Operations, Regulatory Affairs, Clinical Data Management, Pharmacovigilance, Medical Writing, and Site Management. Employees work on global clinical trials that contribute to the development of life-changing therapies while gaining exposure to international regulatory standards and advanced clinical technologies. Parexel Site Start-Up Specialist Vacancy Details Parexel is recruiting for the following position: Company: Parexel Designation: Site Start-Up Specialist Department: Clinical Trials Category: Clinical Operations / Site Start-Up Experience: 12 Years Job Location: Hyderabad, Telangana Employment Type: Full-Time This opportunity is ideal for professionals seeking careers in Clinical Research, Site Activation, Regulatory Affairs, Clinical Operations, and Clinical Trial Management. Job Role & Responsibilities The Site Start-Up Specialist will support regulatory and investigator site activities to ensure timely activation of clinical trial sites while maintaining compliance with international quality standards. Key responsibilities include: Site Initiation & Regulatory Activities Support regulatory submissions for clinical studies. Coordinate submission of documents to Central Institutional Review Boards (CIRBs). Assist investigator sites with Local Institutional Review Board (LIRB) submissions. Coordinate Clinical Research Organization (CRO) insurance requests. Distribute complete regulatory document packages to investigator sites. Coordinate document translation activities with external vendors. Perform due diligence checks on regulatory documentation. Investigator Site Documentation Collect, review, and track investigator site essential documents. Prepare and review regulatory packages for site activation. Ensure compliance with country-specific regulations and ICH-GCP guidelines. Review documentation received from CRO partners. Support document collection activities to meet IRB timelines. Upload essential documents into the electronic Trial Master File (eTMF). Resolve document quality issues promptly. Maintain inspection-ready Trial Master File documentation. Track documentation status and study metrics. Provide regular updates to study teams and stakeholders. Ensure documentation is completed before initial drug shipment. Escalate critical issues when necessary. Eligibility / Qualifications Required Education Bachelors Degree, B Pharm, M Pharm, Pharm D, BSc, MSc, Biotechnology, Biochemistry, Clinical Research, Life Sciences, Biomedical Sciences, Nursing, Healthcare Management, Medical Laboratory Technology (MLT), Bioinformatics, Pharmacy Practice, Public Health or other relevant healthcare and life sciences disciplines. Candidates holding an advanced degree may be considered in place of the required years of experience, as mentioned by the employer. Experience Minimum 12 years of relevant clinical research industry experience. Candidates with advanced qualifications may also be considered. Required Skills Applicants should possess knowledge of: Clinical Trials Site Start-Up Site Activation Regulatory Documentation Clinical Research Trial Master File (TMF) Electronic Trial Master File (eTMF) ICH-GCP Guidelines Clinical Operations Regulatory Compliance Investigator Site Documentation Institutional Review Boards (IRB) CRO Operations Microsoft Excel Microsoft Word Microsoft PowerPoint Microsoft Project Preferred Skills Medical Terminology Clinical Drug Development Inspection Readiness Documentation Review Time Management Stakeholder Communication Problem Solving Quality Management Document Tracking Systems Location & Salary Job Location Hyderabad, Telangana Estimated Salary Based on current Clinical Research Organization (CRO) salary trends in India, professionals working as Site Start-Up Specialists with 12 years of experience may expect an estimated annual salary of: 6.5 Lakhs to 10 Lakhs per annum The .