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Scientific. Clinical. Software Engineering

Clinical Research Medical Advisor (MD)

New Jersey All, NJ

Job Type: Clinical Job Number: JN -062020-26891 Region: New Jersey All

Job Description

This role is key for medical supervision and medical management of clinical trials

The Medical Advisor (MA) is the medical link between Medical Operations (and/or Units/Customers) and (potential) investigators or experts/Key Opinion Leaders (KOLs)

Provide appropriate medical feedback to central clinical trial team especially to Clinical Study Director (CSD) and Feasibility Manager (FM)

Conduct pre-feasibility and/or assess the feasibility of international protocols by collecting information and documentation on the study to be performed and by conducting surveys with opinion leaders, experts or potential investigators as Health Authorities according to Clinical Study Director (CSD) and Feasibility Manager (FM) (Medical Operations) requirements and timing

Serve as "Medical" liaison and ensure appropriate collaboration with the Global team (CSD, FM)

Serve as first-line medical support to teams e.g. answer medical questions from investigating sites, Ethics Committees, monitoring teams (MTs), study managers

Conduct appropriate review of patients, data (e.g. patient profiles, e-CRF data), especially for critical cases (outcome events, related SAEs, AEs with pre-specified monitoring) in order to support MT and CSO and get data quality

Provide expert scientific advice and leadership while managing a broad range of activities associated with the assigned product(s) and therapeutic area(s)

Responsible for local scientific knowledge and lobbying allowing capture of country specific information on competitive intelligence and validation of global hypothesis from the Clinical Development Plan or assessment of Extended Synopsis (ES)/protocol contents

Serve as preferred point of contact for Medical Operations to review and to provide medical input on proposed ES, protocol and/or Clinical Development Plan and medical practices

Promote participation for any clinical study and maintain and expand the investigator network across Region; ensure quality of local/regional Investigator Meetings regarding medical content, ethics and interaction with investigators

Maintain a network of experts and potential investigators within your therapeutic field and region; identify potential investigator's site competence and their capacity to respect the trial commitments; approve site selection

Support the affiliate's network of Key Opinion Leaders (KOL) and experts when selecting national Coordinators or members of Study Committees

Ensure medical and scientific training to the monitoring team and others including a good understanding of material provided by the Global team

Contribute to the exchange of relevant information between R&D and marketing department regarding clinical activity and support the handover of R&D products to marketed compounds

Requirements:

MD with a minimum of 4-6 years of medical monitoring, clinical development and/or clinical science experience from a pharmaceutical or biotech company is required


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