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5-7 years
Not Disclosed
10 July 29, 2025
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

 

Clinical Trial Lead – Catalyst Clinical Research (Remote)

Job Summary:

Catalyst Clinical Research is hiring a Clinical Trial Lead to manage and oversee a team of Clinical Research Associates (CRAs) conducting global oncology and multi-therapeutic trials. In this remote position, you will be responsible for site evaluation, monitoring activities, CRA performance, regulatory compliance, and client communications. You will play a pivotal role in ensuring the clinical integrity, regulatory adherence, and successful delivery of each study.


Key Responsibilities:

  • Oversee CRA activities including site initiation, monitoring, and closeout

  • Participate in site feasibility and selection processes

  • Review monitoring reports, track CRA performance, and resolve site issues

  • Ensure CRA and site staff are trained on therapeutic areas and protocols

  • Collaborate with Project Management on risk assessment and mitigation

  • Conduct co-monitoring visits and coach CRAs as needed

  • Draft study documents: Clinical Monitoring Plans, SOPs, lab manuals, etc.

  • Manage safety documentation distribution, SAE tracking, and compliance

  • Plan and participate in Investigator Meetings and site communications

  • Maintain Trial Master File and ensure document completeness

  • Contribute to study audit preparation, data trend analysis, and enrollment planning

  • Support protocol compliance and issue escalation for effective trial execution


Required Skills & Qualifications:

  • Education: Bachelor's degree in Life Sciences or relevant healthcare field

  • Experience:

    • 5–7 years of field monitoring experience

    • 1–2 years as Lead CRA or Clinical Trial Lead, preferably in oncology

  • Certifications: GCP certified

  • Strong knowledge of ICH-GCP, FDA/EMA/MHRA regulations

  • Skilled in EDC, CTMS systems, SharePoint, and Microsoft Office Suite

  • Excellent communication, leadership, and mentoring skills

  • Able to handle multiple studies and meet deadlines

  • Willingness to travel up to 30%

  • Experience managing remote teams and facilitating team meetings


Perks & Benefits:

  • 100% Remote work flexibility

  • Work with leading biotech sponsors on cutting-edge oncology trials

  • Collaborative and innovation-driven global team

  • Competitive compensation (exact salary not specified)

  • Professional development and performance-based recognition

  • Exposure to global clinical operations and regulatory processes


Company Overview:

Catalyst Clinical Research is a global contract research organization (CRO) providing expert-driven, flexible solutions across oncology and multiple therapeutic areas. With a focus on scientific excellence and client satisfaction, Catalyst accelerates innovative clinical development and helps bring life-changing treatments to patients faster.


Work Mode: Remote
Job Type: Full-Time
Experience Level: Mid to Senior (5–7+ years)


Apply Now

Advance your career in clinical operations with Catalyst Clinical Research. Take charge of impactful global trials as a Clinical Trial Lead. Apply today and lead innovation in clinical research.