Regional Medical Monitor (RMM)

The Regional Medical Monitor (RMM) represents BU Clinical and is dedicated to local/regional medical oversight in clinical trials of high medical risk. They also contribute to management of significant medical/safety issues in non high risk studies. RMMs ensure global consistency of medical oversight of study sites in their assigned region.
RMMs support Clinical Leads of a Study (CLS) with country intelligence input to any clinical development program, country strategy, and protocol design.
The RMM may also act as RMM Study Lead. In this role, the RMM is the main RMM point of contact to the CLS for overall study related issues, and representing the RMMs assigned to the study he/she leads.

Responsibilities:

As Individual Contributor RMM:
1. Program country strategy, pre-feasibility and site selection (all studies)
 Provide scientific and technical input, from a regional perspective, including input from Medical Affairs and external clinical experts, on the Program Feasibility, Country Strategy, and Protocol Design summarizing any country intelligence (e.g. standards of care, or other medical relevant information) through the CLS.
• Discuss about best sites to consider for planned clinical trials in the countries for which they are responsible (e.g. via Pfizer Site Recommendation/iMAP process), and supports the CLS in reviewing the proposed list of study sites for the relevant countries.
2. Medical issues
• Is responsible for medical issue resolution understood as:
o Significant medical issues (all studies)
 Potential/actual critical medical qualifying quality issues (QQIs, request of CLS for non high risk studies)
 Complex safety issues (request of the CLS for non high risk studies)
 Corrective And Preventive Actions (upon request of the CLS)
o Other medical issues (high risk studies)
 Reactive medical support to facilitate ethics/regulatory approvals
 Medical questions from investigator/monitor/Compliance Oversight Lead
 Protocol Deviations with potential medical/safety implications
 Addressing unusual data for major endpoints or for safety
 Study interruption relating to benefit/risk
 Review of study documents / translations (e.g. Informed Consent Document) only upon request due to significant changes to medical wording
 Helping investigators to understand how patients in their medical practice can be recruited ie. align with protocol inclusion/exclusion criteria
3. Training (high risk studies)
• Attends investigator meetings of the protocols he/she is responsible for when possible
o In agreement with the CLS, can present some agenda items (e.g. role of the RMMs, safety procedures)
• Address specific investigator knowledge gaps during site visit
• Provide the retraining associated with significant medical site quality issues (e.g. as part of site based Corrective and Preventive Activities), ensuring investigators are engaged with the protocol and understand the importance of quality and rigour in collection of key data supporting the integrity of the study
• Site initiation visits when associated with a specific need to address risk to quality / patient safety (agreed with clinician), eg. identified in the RMM Medical Oversight Plan (MOP)
4. Site Visits/contact with sites
• Targeted site visit (or other contact forms as needed) to address specific medical issue or need (high risk studies – but also for all studies for critical medical issue)
o Follow up on Serious Adverse Events to enable clear narrative
o Potential / actual Qualifying Quality Issues
o Protocol Deviations and/or Site Visit findings with potential medical impact
o Identified specific investigator re-training need
o Accompany auditor on targeted audit where specific medical expertise is required
o Other (e.g. need for medical review of patient notes, audit findings)
• Proactive site visit (or other contact forms as needed) based on the relevant risk factors identified in the RMM MOP to address potential site based risk (high risk studies)
o When agreed with CLS
o When consistent with specific risk mitigation plans
o Ideally conducted in conjunction with site monitor
As RMM Study Lead:
1. As an RMM Study Lead (RMMSL), the individual is responsible globally for country-level medical oversight of a high medical risk study and represents the group of RMMs from different countries to the CLS/global Study Team.
2. The RMMSL ensures timely communication between CLS and all assigned RMMs (including occasional meetings) for overall study related issues. This may include presenting RMM activities to the CLS, sharing risk management tools (such as the RMM Medical Oversight and Integrated Quality Management Plans), study updates, safety reports, best practices and lessons learned, compiling from country RMMs local information requested by the CLS.
3. Provides effective and consistent inputs into protocol Quality Management Plans
4. Facilitates consistency and alignment of RMM medical oversight across countries, utilizing the RMMSL checklist including eg. creating and maintaining the RMM MOP, and ensuring systems are up-to-date with RMM role.
5. May provide training to other RMMs, on behalf of the CLS, when indicated.
6. Shared with the line manager, may coach/mentor less experienced RMMs.

If you meet the selection requirements for above mentioned position and you are interested to participate in the selection process, please send your CV directly to following email address:
[email protected]