09 ago
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The Medical Affairs Company (Tmac)
|
El Grao de Castellón
09 ago
The Medical Affairs Company (Tmac)
El Grao de Castellón
Territory includes but not limited to: All of EU countries as needed
The Regional Medical Director (RMD) is an integral member of the metabolic/obesity clinical sciences group, who assists and extends Clinical Sciences across the metabolic portfolio on assigned studies at the regional level .
Duties and Responsibilitie
s:
Site engagement and training
o A cadence of touchpoints with sites on a regular basis
o Meeting with sites and presenting at PSVs, SIVs
o Retraining as needed (e.g., due to amendments)
Recruitment issues
o Site identification/recruitment: Meeting with potential sites, in collaboration with CTL, to discuss the program/assess of their interest
o Patient recruitment issues (ongoing oversight): Meeting with sites, in collaboration with CTL, to help understand the hurdles with recruitment at their site and trouble shooting
Answering questions from sites
o Helping address site medical/clinical questions as a first line for those questions that are straightforward or previously addressed or to help coordinate a response with the Medical Director for those that are not straightforward/new
This includes referencing and updating the FAQ, as applicable
Medical Director should always be copied on the email correspondence for oversight
Assisting with eligibility assessments
o Help perform eligibility checks or address urgent eligibility questions prior to randomization
Assisting with query closure
o Helping site understand what is needed to close a medical query if there is a misunderstanding from the site regarding what is needed
Feedback should also be provided to the study team if the query text could be improved for clarity
o Helping ensure that the information that we must have to describe a safety event is sufficient, including:
Ensuring that all information has been gathered as expected (i.e., the site has taken all reasonable steps to obtain the information, etc.) in collaboration with the CRA, if additional support is needed during escalatio
📌 Regional Medical Director (El Grao de Castellón)
🏢 The Medical Affairs Company (Tmac)
📍 El Grao de Castellón