Clinical Operations Specialist - Sponsor Dedicated

2+ years

Not Disclosed

France

10 Jan. 22, 2025

Job Description

Job Type: Remote Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Operations Specialist - Sponsor Dedicated
Location: France (Europe)
Job ID: 25001327
Updated: January 20, 2025

Company Overview:

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We leverage clinical, medical affairs, and commercial insights to address modern market realities. Our Clinical Development model centers around the customer and patient, continuously seeking ways to streamline operations for more efficient outcomes.

Syneos Health is committed to fostering an environment where diversity of thought, backgrounds, and perspectives is celebrated. Our goal is to build a company that is both a great place to work and one that our customers trust and rely on.

Why Syneos Health:

Career Development: We provide opportunities for career growth and progression, supported by engaged line management, technical and therapeutic area training, and peer recognition.
Inclusive Culture: Our Total Self culture ensures that employees can be their authentic selves, united globally by shared values.
Diversity and Belonging: We value diversity and are continuously creating a space where everyone feels they belong, leveraging diverse perspectives to fuel innovation.

Position Overview:

The Clinical Operations Specialist (COS) will assist with site management activities, ensure compliance with study protocols, and maintain trial-related documentation. This role is a hybrid position that involves collaborating with clinical teams and providing support across various clinical operations functions.

Key Responsibilities:

Compliance & Operations:
- Perform activities in accordance with Corporate and Clinical Operations Policies, SOPs, and Work Instructions.
- Support Clinical Monitoring teams in site management and serve as a Sponsor representative on assigned studies, ensuring compliance with protocols, procedures, and guidelines.
Document & Data Management:
- Assist in creating and maintaining the Trial Master File (TMF) and other project files, including participation in audits.
- Prepare site manuals, reference tools, and other documentation as needed.
- Track and update clinical and regulatory documents for investigator sites, studies, project teams, or clients.
Logistics & Coordination:
- Manage shared mailboxes, process site requests, and route correspondence appropriately.
- Coordinate the ordering, packaging, shipping, and tracking of site supplies and materials.
- Assist in scheduling and coordinating team meetings, preparing accurate meeting minutes and action items.
Case Report Forms & Queries:
- Handle the receipt, tracking, and disposition of Case Report Forms (CRFs) and queries.
Training & Awareness:
- Maintain awareness of clinical research developments by completing all required training.

Qualifications:

Education: High School diploma or equivalent required.
Experience: Previous clinical trial experience is beneficial.
Skills:
- Strong communication and interpersonal skills.
- Ability to embrace new technologies and adapt to changing requirements.
- Organizational skills with a keen attention to detail.
Travel: Minimal travel (up to 25%) may be required.

About Syneos Health:

Syneos Health has played a crucial role in the development of 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and conducted over 200 studies across 73,000 sites with more than 675,000 trial patients.

Additional Information:

Tasks, duties, and responsibilities are not exhaustive. The company may assign additional responsibilities at its discretion.
Equivalent experience, skills, and/or education may be considered as a substitute for the qualifications listed in this description.
Syneos Health is committed to compliance with the Americans with Disabilities Act (ADA) and providing reasonable accommodations when appropriate.

Apply Now: [Application Link]
Join Our Talent Network: Stay connected to future career opportunities.

Syneos Health is an Equal Opportunity Employer. We value diversity and encourage all qualified individuals to apply, even if their experience doesn't align perfectly with the job description.

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Clinical Operations Specialist - Sponsor Dedicated

Job Description

Company Overview:

Why Syneos Health:

Position Overview:

Key Responsibilities:

Qualifications:

About Syneos Health:

Additional Information:

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