(US-New Jersey) For more than a century, our client has been working to advance health care for people around the world. They have evolved into a diversified health care company that discovers, develops, manufactures and markets innovative products and services that span the continuum of care from prevention and diagnosis to treatment and cure. They provide total integrated solutions across the health care spectrum for some of the worlds most prevalent medical conditions, including AIDS, cancer and diabetes. Our client, a major pharmaceutical company in Parsippany, NJ is looking for a Senior Clinical Research Associate - D with the following qualifications: REQUIRES 7+ YEARS EXPERIENCE Member of the clinical team responsible for conducting Phase I - IV studies according to Federal Regulations and ICH guidelines and study protocol, including planning study conduct, writing study protocols, designing CRF's, CRO selection, CRO training and management, selections and training of study investigators, planning and running study meetings, and overseeing the evaluation, selection and training of new study investigators. Responsible for the initial budget and contract negotiations with study sites or CRO's. Responsible for writing and supervision of contributors of clinical reports and NDA documents, including integrated Summaries of Safety and Efficacy (ISS and ISE), as appropriate. BS/MS Preferred. This job may go on longer than December 31. You MUST meet all of the above qualifications in order to be considered for this position. You MUST be either a US Citizen or a Green Card Holder in order to be eligible for this position.
(US-Massachusetts-Framingham/Worcester) Under minimal supervision, the Senior Clinical Project Manager acts as the liaison with clients while managing project teams to ensure quality service. Responsibilities encompass the overall management of a project including budgeting, timeline adherence, internal and external communications, project deliverables. Serves as point of contact for internal and external customers. Serves as mentor and leader within the Project Management Department. Required qualifications: *Bachelor’s degree *5-7 years experience working within the pharmaceutical/biotech industry *2+ years project management experience. *Must have the ability to handle multiple projects simultaneously and manage multi-functional teams; must have creative problem solving skills *Excellent verbal/written communication skills. *Must have strong computer, time management, and organizational skills. *Must have excellent and superior knowledge of at least two departmental processes and functions within the Pharmaceutical Industry and drug development process. Preferred qualifications: 2+ years project management experience within a CRO; 3 years management experience.
