Quotient are recruiting for a Clinical Affairs Associate Manager to join the Clinical Affairs team based in US. This role will be responsible for successful execution of assigned clinical field trials within budget and in conformance with global regulations and internal policies and procedures.
The main responsibilities will include:
Responsible for creating clinical strategy, planning and management of all Quotient clinical field trials related to MosaiQ including related management of potential contracted organizations conducting field trials in foreign countries.
Responsible for overseeing all clinical activities related to one or more clinical studies as well as performing and/or managing the daily operations associated with the studies.
Negotiate and administer, in conjunction with the Finance and Administration Department, all activities with potential field trial sites and/or Contract Research Organizations concerning contracts and activities including adherence to SOPS, protocols, and medical evaluation according to parameters of each field trial.
Work with physicians on an individual and group level to develop and execute clinical field trials that meet company Marketing, Regulatory and R&D requirements.
Responsible for the completion, compliance and assessment of safety/efficacy reports as required by the Food and Drug Administration (FDA) and international regulatory bodies, clinical development plans, and research strategies.
A relevant science degree or professional qualification.
Significant specialist knowledge of clinical affairs as applied to in vitro diagnostic medical devices and instrumentation.
A working knowledge of GMP, ISO 13485 and IVDD requirements.
Communicate with external suppliers and customers.
Good presentation skills.
Ability to travel internationally (approximately 25%) will be an essential part of this position.
Telecommuting is allowed.
Quotient is a commercial-stage diagnostics company committed to increasing efficiencies and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and donor disease screening (transfusion diagnostics), Quotient is developing MosaiQ™, its next generation automation platform to address the comprehensive needs of the global transfusion diagnostics market. Once approved for sale, MosaiQ™ will be the first automated solution for blood grouping, quickly and comprehensively characterizing both donor and patient blood, improving patient outcomes and eliminating the need for expensive and time-consuming manual testing. MosaiQ™ will also undertake all mandated serological disease screening tests required for donor blood. Quotient has over 30 years of experience developing, manufacturing and commercializing transfusion diagnostic products. The company’s operations are based in Switzerland, Scotland and the US.