Clinical Trial Manager – Cardio
Worldwide Clinical Trials
Senior Clinical Trial Manager – Clinical Research Medical Advisor
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Lead local clinical/medical aspects of trial implementation, including protocol review, site selection support, feasibility assessments, and recruitment strategy planning.
- Act as the medical representative to support study design, regulatory interactions, and site training to ensure protocol adherence and patient safety.
- Identify pro actively recruitment challenges or operational challenges and develop migration plans.
- Provides protocol/compound and indication trainings to internal and external partners
- Provide medical input for Informed Consent Forms (ICFs) and safety reporting.
- Partner with clinical operations, regulatory, medical affairs, and external experts to optimize trial execution.
- Support safety oversight: review serious adverse events (SAEs), provide pharmacovigilance support, and ensure clinical data quality.
- Contribute to early trial start-up by validating study feasibility and supporting site engagement and training.
- Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and country regulations.
- Contribute to internal and external scientific discussions, including advisory boards and investigator meetings.
- Provide clinical/medical expertise for regulatory inspections, audits, and trial documentation.
Requirements
- Advanced scientific degree: M.D., Ph.D., or Pharm.D. (M.D. preferred); subspecialty training desirable.
- Local Language fluency required
- Fluent in English (speaking and writing)
- Minimum 3 years in clinical development or clinical practice in the pharmaceutical or healthcare sector.
- Strong understanding of clinical trial design, implementation, and ICH/GCP principles.
- Proven ability to analyze complex clinical/scientific issues and provide practical solutions.
- Strong communication and leadership skills to work cross-functionally.
- Problem-solving mindset and agility across therapeutic areas.
- Excellent presentation skills in English and local language.
- Strong protocol review and feasibility assessment skills.
- Understanding of safety and regulatory requirements in clinical trials.
- Experience supporting regulatory submissions, audits, and inspections.
Benefits
- Professional development opportunities
- Total rewards program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial designprotocol reviewfeasibility assessmentsafety reportingpharmacovigilanceGood Clinical Practice (GCP)ICH guidelinesregulatory submissionsclinical data qualityinformed consent forms (ICFs)
Soft skills
communication skillsleadership skillsproblem-solving mindsetagilitypresentation skillsanalytical skillscross-functional collaborationtraining skillsstrategic planninginterpersonal skills
Certifications
M.D.Ph.D.Pharm.D.
