Clinical Research Regional Area Managers - CA

Clinical Research Senior Regional Area Manager required for a thriving pharmaceutical firm in California.

Our client is looking to hire up to four Clinical Research Regional Area Managers to serve as a key liaison and monitoring lead assigned to a specific therapeutic area and also act as a Global Therapeutic Lead.

In this role the successful candidate will provide leadership, supervision and quality oversight of monitoring to specific regional and geographic monitoring teams.

As the Regional Area Manager you will be expected to lead, manage and motivate Clinical Research Associates to deliver on all clinical trial commitments, to ensure the overall quality of site management and monitoring work performed by Clinical Research Associates, to provide a single point of contact for therapeutic teams and other stakeholders, to align execution activities with agreed-upon project priorities, timelines, quality/productivity specification, in compliance with GCP and local laws and regulations governing the conduct of clinical research.

You will be expected to take responsibility for Regional Site Management and developing Global Clinical Site Management and Monitoring staff, act as a territory development specialist for the strategic assessment and development of geographic territories to increase the number of qualified sites and investigators available for clinical trial participation. You must also provide regional study support and coordinate activities that provide feasibility data regarding clinical protocols and providing recommendation for global study placement in the region.

As a Global Therapeutic Area Liaison you will be expected to create a strong relationship with the clinical team and study managements teams to the rest of the business. You will also act as a resource for therapeutic area teams on all global operational issues. You will also be expected to source strategy for all studies within a chosen therapeutic area and collaborate with other regional managers and feasibility specialists, providing oversight for the conduct of therapeutic-specific site-level feasibility.

For this role you strong experience with a Bachelors or Masters degree, preferably a MD or PharmD. A post graduate qualification in life science or equivalent is preferred, specifically in one of the following therapeutic areas ophthalmology, neurology, dermatology, urology and medical aesthetics.

You should have strong experience clinical study site monitoring and/or management experience of all stages of clinical trials (i.e. feasibility to study close-out), with international operations experience preferred. You should have field monitoring experience on regional studies in the international market place and should have experience from within a CRO and a sponsor (pharmaceutical) business. You should also have proven line management responsibilities.

You should have a good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations, when country-based.

On offer is a competitive salary and an outstanding opportunity to join a strong firm which is going from strength to strength.

This role involves 50% travel domestically and internationally and domestic relocation is offered.

This position, Clinical Research Regional Area Managers - CA, was posted on February 25, 2011. Since this job has been published, it has been viewed 29 times.