Role Description
The Sr. Clinical Trial Manager (Clinical Research Medical Advisor) is responsible for providing medical and scientific leadership to ensure the high-quality execution of clinical trials and studies in the assigned country or cluster. This role bridges Clinical Development and cross-functional teams, ensuring local medical input and compliance with regulatory standards.
Key Responsibilities
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Lead local clinical/medical aspects of trial implementation, including protocol review, site selection support, feasibility assessments, and recruitment strategy planning.
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Act as the medical representative to support study design, regulatory interactions, and site training to ensure protocol adherence and patient safety.
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Identify proactively recruitment challenges or operational challenges and develop migration plans.
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Provide protocol/compound and indication trainings to internal and external partners.
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Provide medical input for Informed Consent Forms (ICFs) and safety reporting.
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Partner with clinical operations, regulatory, medical affairs, and external experts to optimize trial execution.
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Support safety oversight: review serious adverse events (SAEs), provide pharmacovigilance support, and ensure clinical data quality.
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Contribute to early trial start-up by validating study feasibility and supporting site engagement and training.
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Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and country regulations.
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Contribute to internal and external scientific discussions, including advisory boards and investigator meetings.
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Provide clinical/medical expertise for regulatory inspections, audits, and trial documentation.
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May work cross country.
Qualifications
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Advanced scientific degree: M.D., Ph.D., or Pharm.D. (M.D. preferred); subspecialty training desirable.
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Local Language fluency required.
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Fluent in English (speaking and writing).
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Minimum 3 years in clinical development or clinical practice in the pharmaceutical or healthcare sector.
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Strong understanding of clinical trial design, implementation, and ICH/GCP principles.
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Proven ability to analyze complex clinical/scientific issues and provide practical solutions.
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Strong communication and leadership skills to work cross-functionally.
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Problem-solving mindset and agility across therapeutic areas.
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Excellent presentation skills in English and local language.
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Strong protocol review and feasibility assessment skills.
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Understanding of safety and regulatory requirements in clinical trials.
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Experience supporting regulatory submissions, audits, and inspections.
Requirements
Benefits
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Passionate about developing our people through career development and progression.
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Supportive and engaged line management.
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Technical and therapeutic area training.
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Peer recognition and total rewards program.
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Commitment to building an inclusive culture.
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Opportunity to shape solutions that impact lives.