- San Carlos, United States
- Job Type
- Jeff Fisher
- about 1 month ago
Medical Monitor – Oncology
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.
- 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.
- 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.