Overview
The Clinical Development Medical Monitor is responsible for providing medical expertise across all clinical trials, ensuring participant safety, data integrity, and compliance with protocols, regulations, and ethical standards. The role includes oversight of medical monitoring activities, either directly or in collaboration with CROs, and contributes to building strong scientific relationships with the medical community, under the guidance of the Clinical Development Medical Lead.
The Clinical Development Medical Monitor provides medical monitoring in clinical trials, i.e., continuous oversight of the health and safety of participants, as well as the collection of data related to their physiological and clinical status during a trial. It is a critical component of ensuring participant safety, evaluating the effectiveness of investigational treatments, and maintaining the integrity of the trial\'s data. The monitoring is conducted in accordance with the trial’s protocol, regulatory requirements, and ethical guidelines. If the clinical trial medical monitoring activity is outsourced, the CD Medical Monitor will work in conjunction with the selected CRO and will be responsible, with the Clinical Development Medical Lead guidance, for oversight of delegated activities.
Responsibilities
* Provide medical consultation on clinical trial matters, including participant eligibility (inclusion/exclusion criteria), protocol-related medical questions, efficacy and safety assessment procedures, concomitant medications, adverse events, and guidance on serious adverse event (SAE) reporting.
* Review of SAE narratives.
* Consultation on administration issues of investigational product (IP).
* Ongoing review and classification of Protocol Deviations.
* Ongoing review of exclusionary and alert values of laboratory tests or any other testing data as required.
* Leading of medical teleconferences within the medical monitoring team at Ferrer and/or with external clinical services providers.
* Providing therapeutic and/or protocol training for all relevant study team members.
* Contribution to Institutional Review Board/Ethics Committee (IRB/EC) and/or authority submissions, as needed.
* Review of medical coded terms for consistency and medical appropriateness.
* Review of Participant data listings and patient profiles.
* Support in patient enrolment activities.
* Review and co-author, if necessary, key study documents such as Study protocol, Medical Monitoring Plan, Safety Management Plan, Informed Consent Form, Clinical Study Report, etc.
Why Ferrer?
* Make a positive impact in society
* Participate in volunteering activities
* Grow in a culture of trust, responsibility, and constructive feedback
* Enjoy a flexible working model and collaborative office experience to enable innovation and teamworking
* Make a real difference to the team and to yourself
* Take advantage of opportunities for development and learning
* Discover a range of benefits to support your physical, emotional and financial wellbeing
* Customize your remuneration and benefit
What You’ll Need To Succeed
You will rock at this company if you are a person with empathy, humility, curiosity and optimism. You will rock at this role if you match with:
* Medical Degree with Registration Certificate
* Previous experience in Clinical Research, at least 3 years
* GCP certificate
* Good interpersonal skills with ability to relate to both internal and external stakeholders.
* Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing.
* Strategical thinking
* Ability to work in cross functional teams
If this great challenge matches your profile, then we are waiting for you!
At Ferrer, we guarantee equal treatment and opportunities in recruitment, avoiding prejudices and stereotypes for any reason in the processes of access to the company, assessing only objective criteria such as professional and academic skills and work experience.
Seniority level
* Not Applicable
Employment type
* Full-time
Job function
* Other
Industries
* Pharmaceutical Manufacturing
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