367 matching jobs for “Clinical Study Specialist”

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Thermo Fisher Scientific

Country Approval Specialist

Taipei, Taiwan

Join Us as a Country Approval Specialist (core team) – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 …

Added Oct 16, 2026

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Thermo Fisher Scientific

Country Approval Specialist

Remote, Argentina

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical …

Added Oct 16, 2026

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Thermo Fisher Scientific

Country Approva Specialist

Johannesburg, South Africa

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical …

Added Oct 16, 2026

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Bristol-Myers Squibb

… templates, fallback language, and country playbooks; ensure alignment with protocol requirements and study timelines. Apply SOP‑defined budget parameters and exercise decision‑making up to the authorized threshold …

Added Oct 15, 2026

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IQVIA Holdings

(Senior) Clinical Trial Lead (m/w/d)

Frankfurt, Hesse, Germany +2 locations

The IQVIA Clinical Functional Service Partnerships (Clinical FSP) department provides highly skilled professionals who work as …

Added Oct 15, 2026

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Thermo Fisher Scientific

Senior Safety Specialist

Remote, Bulgaria +1 location 2 postings

Join Us as a Senior Safety Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical …

Added Oct 22, 2026

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Thermo Fisher Scientific

Country Approval Specialist

Remote, Turkey

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical …

Added Oct 16, 2026

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Thermo Fisher Scientific

International Freight Specialist

Taipei, Taiwan

… Join our team at Thermo Fisher Scientific where you'll contribute to managing logistics operations for clinical trials, pharmaceutical products, and scientific equipment. As a Logistics Specialist I, you'll coordinate …

Added Oct 16, 2026

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Labcorp Holdings

Data Specialist III

Bengaluru, India 2 postings

1.Engage client data management during start up. • Create protocol folder(s) for study documentation. • Add entries into individual protocol spreadsheet. • Review Statement of Work (SOW) for …

Added Oct 20, 2026

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IQVIA Holdings

Database Management Specialist

Bengaluru, India

- Develop, validate, and maintain SAS programs for clinical study deliverables. Generate and review Data Validation Listings (DVLs) to ensure data accuracy, …

Added Oct 15, 2026

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IQVIA Holdings

Site Activation Specialist

Madrid, Spain

Site Activation Specialist Global Site Activation Location: Spain Make an impact on patient health! IQVIA’s Global Site Activation …

Added Oct 15, 2026

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Thermo Fisher Scientific

Contract Specialist I

Samorin, Slovakia

… making sure our food is safe or helping find cures for cancer. DESCRIPTION: Join our team as a Contracts Specialist I at Thermo Fisher Scientific, where you'll contribute to our mission to enable customers to make the world …

Added Oct 16, 2026

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Thermo Fisher Scientific

Associate Contract Specialist

Remote, United Kingdom

Added Oct 16, 2026

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Thermo Fisher Scientific

FSP Contract Specialist

Remote, Mexico +3 locations 4 postings

Join Us as a Site Contract Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical …

Added Oct 20, 2026

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Thermo Fisher Scientific

Site Contract Specialist

Ivry-sur-Seine, France

Join Us as a Site Contract Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical …

Added Oct 16, 2026

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IQVIA Holdings

Data Entry Specialist

San Antonio, Texas, United States

Pay posted by employer$25,900–$64,800

… for performing all data entry functions as they relate to the completion of case report forms, by entering study data collected by the research team into the Electronic Data Capture (EDC) system. Data entry personnel …

Added Oct 16, 2026

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Thermo Fisher Scientific

Participation Relations & Resolution Specialist

Austin, Texas, United States

Participation Relations & Resolution Specialist Are You... A critical thinker who asks questions, gathers facts, and considers multiple perspectives before …

Added Oct 16, 2026

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Thermo Fisher Scientific

Principal Country Approval Specialist

Remote, Poland

… taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research …

Added Oct 16, 2026

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Thermo Fisher Scientific

FSP Associate Contract Specialist

Remote, Argentina +2 locations 4 postings

Join Us as an Associate Site Contract Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical …

Added Oct 16, 2026

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Regeneron Pharmaceuticals

Sr. Specialist, Medical Coding

Hyderabad

Full time
Regular

… and commercializing medicines that change lives for people with serious diseases. We are seeking a Senior Specialist, Medical Coding to join our Clinical Data Management team. You will independently manage medical coding …

Added Oct 16, 2026

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Thermo Fisher Scientific

Country Approval Specialist

Taipei, Taiwan

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About this opportunity

Original employer description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Country Approval Specialist (core team) – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.

What You’ll Do:
• Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
• Provides project specific local SIA services and coordination of these projects.
• May have contact with investigators for submission related activities.
• Key-contact at country level for either Ethical or Regulatory submission-related activities.
• Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieves PPD’s target cycle times for site.
• May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• May develop country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
• Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Education and Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
• Effective oral and written communication skills
• Excellent interpersonal skills
• Strong attention to detail and quality of documentation
• Good negotiation skills
• Good computer skills and the ability to learn appropriate software
• Good English language and grammar skills
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently, under direction, as required
• Basic organizational and planning skills
• Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
Working Conditions and Environment:
• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves

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