Instagram
youtube
Facebook

Sr Clin Ops Specialist

2+ years
Not Disclosed
10 Nov. 29, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Senior Clinical Operations Specialist

Company: Syneos Health
Location: Global


About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We aim to provide innovative solutions in clinical development, medical affairs, and commercial strategies to meet modern market needs.

"Work Here Matters Everywhere"


Why Syneos Health?

At Syneos Health, we are committed to the development of our people through career growth opportunities, mentoring, technical training, and recognition programs. Our Total Self culture celebrates authenticity, inclusion, and diversity, helping us build a company where everyone feels they belong.


Role Overview

As a Senior Clinical Operations Specialist, you will play a key role in supporting clinical research activities, ensuring compliance with clinical trial protocols, and managing project-related documentation and communications. You will also assist in site management, study coordination, and contribute to maintaining clinical tracking databases.


Key Responsibilities

  • Clinical Operations & Site Management:

    • Support clinical monitoring teams and serve as a sponsor representative for assigned study sites.

    • Ensure that sites comply with protocol requirements, study procedures, and regulatory guidelines.

    • Coordinate with sites to manage supplies, documents, and materials related to the clinical trial.

  • Documentation & Data Management:

    • Create, maintain, and track project files and correspondence, ensuring accuracy and compliance.

    • Update clinical tracking systems and maintain databases with clinical and regulatory documents.

    • Track incoming and outgoing documents, routing them to relevant parties (investigator sites, project teams, clients).

  • Team Coordination & Meeting Support:

    • Assist in organizing and coordinating team meetings, attending meetings, and preparing meeting minutes.

    • Ensure that action items from meetings are followed through to completion.

  • Issue Resolution & Problem-Solving:

    • Proactively identify potential issues and implement corrective actions. Seek guidance as needed to resolve more complex challenges.

  • Training & Mentorship:

    • Provide training and mentorship to junior-level Clinical Operations Specialists (COS), helping to improve skills and knowledge within the team.

  • Clinical Research Awareness:

    • Stay informed on clinical research trends and complete necessary training to maintain industry knowledge.


Qualifications

Education & Experience:

  • Associates degree preferred, or equivalent experience in clinical research, pharma, or biotech.

  • Experience in clinical research or related fields can substitute for the degree requirement.

Technical Skills & Knowledge:

  • Strong understanding of medical terminology, clinical data, and ICH/GCP guidelines preferred.

  • Ability to manage multiple tasks simultaneously, prioritize effectively, and maintain high accuracy.

  • Comfortable with new technologies and tools related to clinical operations.

Soft Skills:

  • Strong attention to detail, organizational skills, and time management.

  • Excellent communication, presentation, and interpersonal skills.

  • Ability to work collaboratively within a diverse team environment.

Other Requirements:

  • Minimal travel (up to 10%) may be required.


Why Work with Us?

  • Career Development: Opportunities for growth and mentoring within a supportive work environment.

  • Impact: Play a crucial role in ensuring the success of clinical trials and regulatory compliance.

  • Inclusive Culture: Be part of a team that celebrates diversity and promotes a culture of belonging.

  • Comprehensive Benefits: Competitive salary, health benefits, 401k, flexible PTO, and more.


Apply Now to join Syneos Health and be part of a team shaping the future of clinical research.


Syneos Health is dedicated to creating an inclusive and authentic workplace. We encourage applicants from diverse backgrounds to apply, even if their experience doesn’t align perfectly with the qualifications listed. Join our Talent Network for future career opportunities.