Medical monitor job description
This post includes 3 parts: duties list, job qualification and job description writing tips for Medical monitor in details A complete job de...
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This post includes 3 parts: duties list, job qualification and job description writing tips for Medical monitor in details A complete job description concludes Medical monitor key duties/responsibilities, Medical monitor job qualifications (knowledge, education, skills, abilities, experience…KSA model) and other ones such as daily tasks, key activities, key/core competencies, job functions/purpose…
I List of Medical monitor duties:
- Provide medical oversight regarding protocol exemptions, protocol violations, protocol
eligibility issues, accepted medications, and general medical-related study issues - Review laboratory alerts, and coordinate appropriate follow-up with study site
- Conduct a medical review of the SAP, Project Plan, Tables and Listings, and the
Integrated Clinical Study Reports as appropriate - Conduct training for the project team concerning the disease, drug, study design and
procedures - Provide consultation to the study team during review of out-of-range laboratory values
for clinical and /or protocol significance - Preview listings, lab reports, and subject profiles as defined within the Safety Medical
Monitoring Plan - Ensure all protocol inquires and answers are documented
- Additional tasks may involve attendance and participation at Investigator Meetings,
preparation of subject narratives, review of study reports and other documents,
preparation and/or review of periodic and interim safety reports
II List of Medical monitor qualifications
1. History of board-certification and/or board-eligibility (or the local country equivalent)
o Medical specialty is strongly preferred, as this indicates successful completion of additional post-graduate medical training
o Medical specialty is strongly preferred, as this indicates successful completion of additional post-graduate medical training
2. Certification to practice medicine, such as a medical license or the local country equivalent
3. Clinical Development Expertise - Demonstrates an understanding of the required steps to progress a new chemical lead through the stages necessary to allow it to be tested in human clinical trials Demonstrates the ability to ensure high quality in the design, development, execution, statistical analysis, clinical interpretation and reporting of clinical studies
4. Good Clinical Practice Knowledge - Demonstrates the ability to ensure an investigation is conducted according to Good Clinical Practice regulations and internal control documents, in order to protect the rights, safety, and well being of subjects and the accuracy and validity of the trial data Ensures the study is in a continuous state of inspection readiness
5. Clinical Judgment Experience - Has demonstrated a proven track record of effectively applying medical expertise to make good clinical decisions, in accordance with appropriate SOP(s)
6. Scientific & Medical Knowledge - Demonstrates a current, in-depth understanding of the relevant drug and associated therapeutic and disease area
7. Clinical Data Stewardship - Demonstrates an understanding of the critical importance of rigorous data generation and disciplined stewardship of the data
8. Medical Monitoring / Pharmacovigilance - Demonstrates an understanding of the detection, investigation, assessment and prevention of adverse effects of medicines on patients Knows when to involve the Safety Development Leader for escalation eg, to the Chief Medical Officer, Global Safety Board
9. Scientific Writing - Demonstrates the ability to produce written scientific communications with clarity, accuracy and rigour and in compliance with GSK control documents governing disclosure, publication and principles of scientific exchange
10. Scientific Presentation - Demonstrates the ability to communicate effectively through formal presentation and through informal scientific discussion with credibility, accuracy, and confidence with internal and external stakeholders and experts
11. Strategic Thinking - Maintains competitive advantage by ensuring the application of the principles, tools and systems from Simplifying Clinical Development
III. Tips to write job description
1. Too-long job description:
Looking at a too-long job description can frighten the candidates off and drive the away. A job description, no matter how important the job is, should not be included in more than 3 pages. If one focuses on too many things at a time, he shall definitely lose focus on the main items and get overwhelmed by the remaining; So, keep it concisely.
2. Too-short job description:
While too-long can be a problem, too-short is more a problem. It will ruin the meaning of the job description. A too-short one means it lacks necessary details and therefore, the candidate will not be able to understand while reading it.
3. Listing unnecessary functions or job duties:
Just classifying these into the “others” category will save you a lot of effort and space. On the other hand, the job description will become more dilute and easy to be neglected.
4. Key functions
Not listing key functions as required for the job can be a fatal mistake to a job description.
5. Grammar and spelling
Poor grammar and having spelling errors can ruin the job description, too. Never think that as you are the employer, you may have the right to make grammar or spelling errors while requires other not to. A job description with such errors is easily to be mistaken as a fake or ghost ads; as a result, the candidate will turn away from it.
6. Not specific enough:
Be specific and concise; if you don’t address the specific, then what the job description is for. It is for the candidate to understand just exactly what he needs to do or needs to have. Lacking details can confuse the candidates very well.
7. Not having the job description reviewed by others:
This is also a common mistake. One may be subject to bias, but more than one, especially with the help of those external advisor, the job description can be more perfect.
8. Using buzzwords or abbreviations:
In fact, it is not necessary at all to use such in a job description.
9. Using slang or legal words:
Just use common wording to communicate with others and don’t do anything extraordinarily.
10. Not updating the job description:
The same job may require different duties and responsibilities in different times, so, you cannot use the same job description for 2 different times.
