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location: Bridgewater, New Jersey
job type: Contract
salary: $78.84 - 92.76 per hour
work hours: 9 to 5
- 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).
- You should be the medical support in the territory for the studies you are allocated to.
- You should 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 (e.g. Firecrest modules).
- 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.
- Ensure all activities under your direction comply with the company, Clinical Development Standard Operating Procedures (SOPs), Good Clinical Practices and regulations..
- Requirement: MD
- Years of Experience: 3 - 6 Years
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.