Job Description

The Senior Medical Services Manager will be responsible for performing higher complexity medical monitoring tasks, including those as a global/program medical monitor. The Senior Medical Services Manager may also mentor/line manage a small number of assigned medical monitors. The activities will include coordination and delivery of training, participation in the development and revision of medical monitoring SOPs, contribution to improving the performance of the medical monitoring team and close liaison with Business Development in medical guidance on protocol and project requirements.

Major Responsibilities

• Perform medical monitoring work with a larger portion as a global/program level medical monitor.
• Keep up to date with current and scientific knowledge in the medical field.
• Work closely with business development and other internal stakeholders in critical appraisal of protocols, proposing study designs and endpoint development.
• Regular participation in project proposals/bid defence meetings and client liaison.
• Set up/support adjudication committees.
• Participate in global/program level governance committee reviews.
• Lead with a data-driven and compliance mindset including detection of trends and outliers, signal detection.
• Provide technical medical support to the team through their own medical knowledge.
• Coordinate, supervise, coach and support assigned medical monitors to improve their service delivery.
• Mentor/line manage assigned medical monitors.
• Participate in the development and revision of medical monitoring SOPs.
• Participate in quality control review and assessment of medical monitoring team performance.
• Update teams’ performance progress and any issues arising promptly to management.
• Manage the fast flow of day-to-day operations.
• Actively participate in recruitment and interviews for new hires.

Qualifications & Experience

Education

• Medical degree from an accredited and internationally recognized Medical School
• Medical Specialist qualification is desirable

Knowledge, Skills, and Abilities

• Knowledge of drug safety reporting requirements and practice
• Attention to detail, strong initiative, critical thinking skills and follow through are essential for this job.
• Computer literate with good experience in using Microsoft Office (Word, Excel, Power Point)
• Excellent knowledge of English usage (both verbal and written with grammar, punctuation, and language)
• Good presentation skills

Experiences

• Experience in clinical practice
• Experience in clinical trials and drug development as an investigator or medical expert in the pharmaceutical, Biotechnology and/or CRO industry

Knowledge, Skills, and Abilities

• Demonstrated ability to deliver work in a fast-paced environment and to independently set priorities and solve problems under tight timelines
• Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction
• Excellent presentation skills
• Strong organization and time management skills
• Ability to engage and build investigator relationships

Experiences

• Experience in global medical monitoring and program level medical oversight including review of all or critically relevant data for consistency, coherency, reliability and medical “logic”
• Experience in complex study designs, wide range of therapeutic indications and ability to assess scientific data
• Prior mentoring/line management experience will be well regarded