Medical Monitor

Medical Monitor – Oncology

JOB SUMMARY:

The individual will serve as the medical monitor for clinical trials of client products throughout their lifecycle. The individual will also, when appropriate, as a result of their medical experience, contribute to clinical development and medical affairs activities as part of the broader team.

A successful candidate will be familiar with the ICH/GCP, regulatory authority’s regulations/guidelines, and applicable SOPs.

This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the program director when needed.

JOB RESPONSIBILITIES:

• Review clinical protocols, study reports, clinical trial supporting materials, and other related documents.
• Engage with clinical team to answer eligibility and other medical related questions associated with clinical trials.
• Provide therapeutic area training.
• Author Medical Monitoring Plan for each clinical trial.
• Safety review and oversight.
• Contribute to regulatory submissions including authoring relevant sections of the submissions.
• Author, review, and provide input for drug-safety related regulatory reports and clinical study documents.
• Contribute to the development of internal processes including SOPs, guidelines, and Work Instructions.
• Act as medical and scientific subject matter expert for expansion of the team’s pharmacovigilance capabilities.

REQUIREMENTS:

• MD or foreign equivalent.
• Postgraduate training with at least 2 years of drug safety, clinical development or medical affairs experience in the pharmaceutical industry.
• Excellent understanding of pharmacovigilance regulatory environment with working knowledge of international regulations, initiatives, standards, Good Pharmacovigilance Practices (GVP), and Good Clinical Practice (GCP).
• Knowledge of MedDRA and WHODrug coding and terminology.
• Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining results.
• Strong attention to detail and excellent organization skills.
• Strong interpersonal skills and communication skills (both written and oral).
• Strong leadership skills, self-motivated, adaptable to a dynamic environment.
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• Preference to energetic candidates with a desire to think “outside the box.”
• Willingness to travel as needed.