Junior Study Start Up Specialist

🔥 16 hours ago

🌐 Spain, United Kingdom – Remote

🇪🇸 Spain – Remote 🇬🇧 United Kingdom – Remote

💵 €30k - €32k / year

⏰ Full Time

🟢 Junior

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 1 day.
• Jobs at this company usually fill in 21 days.

Apply Now

Find Similar Remote Jobs

Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Coordinate and track site feasibility activities • Ensure confidentiality agreements are in place • Collect and maintain regulatory, Competent Authority, and Ethics Committee submission information in JVRIM, CTIS, and similar systems • Ensure clinical trial insurance is in place for submission • Coordinate translations of submission documents • Create, review, and customize country- and site-specific Informed Consent Forms • Secure authorization of regulatory documents and contracts with relevant teams and vendors • Collect and review initial regulatory packets and site contracts • Coordinate site activation activities, regulatory and ethics approvals, and essential-document review for IP release • Prepare ongoing submissions, amendments, periodic notifications, and safety notifications • Ensure relevant documents are submitted to the Trial Master File • Liaise with CRAs, CTMs, contract vendors, and Regulatory Leads to enable rapid trial start-up • Inform team members when regulatory and contractual documents are completed • Attend cross-functional project meetings and provide updates • Identify, resolve, and escalate site issues and risks • Review and provide feedback on site performance metrics • Maintain accurate SSU data tracking entries • Facilitate process improvement efforts • Support development of start-up plans and essential document checklists • Collaborate with regulatory, legal, and clinical operations teams to ensure compliant and efficient trial initiation • Complete required training, timesheets, and expense reports accurately and on time • Maintain knowledge of and comply with Parexel processes, ICH-GCPs, and applicable requirements • Help investigator sites prepare to start clinical trials and reduce site activation timelines

🎯 Requirements

• Bachelor's degree or 3 years' clinical research or other relevant experience, or an equivalent combination of education, training, and experience • Pharmaceutical or related industry experience • Previous experience working in a start-up team, as a Clinical Trial Specialist, or in a similar role, having worked on global clinical trials • Excellent knowledge of GCP and regulations • Ability to work independently in a fast-paced environment • Ability to identify and resolve site issues independently and escalate complex problems effectively • Flexibility and willingness to support process improvement efforts • Excellent verbal and written communication skills • Ability to collaborate effectively with regulatory, legal, and clinical operations teams • Experience with in-house trials or process design preferred

🏖️ Benefits

• Premium salary • Attractive benefits • Medical care plan: Health, Dental & Vision • Life Assurance • Excellent work environment • Culture of teamwork and collaboration • People who motivate and face challenges together • Innovative technology • Excellent training • Paid time off • Health insurance • Additional benefit offerings in accordance with applicable plans • Potential eligibility for additional incentives, bonuses, or other compensation programs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume