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Boehringer Ingelheim Pharmaceuticals, Inc.
Clinical Scientist
Location: Ridgefield,
Connecticut-Danbury/Bridgeport
06877
Posted on:
10/1/2009 11:05:41 AM
Postion type:
Full time
Job Code:
MD05109
Required Education:
Bachelor's Degree
Salary:
DESCRIPTION
Position Summary: Provide critical operational assistance in planning, implementation, conduct, and completion of clinical trials. Provide experienced judgment and recommends action(s) in response to operational clinical trial issues. Seeks input on issues requiring medical judgment and/or management input. Independently executes assignments and initiates actions that ensure the final goals of assigned projects are met. Develops and maintains relationships with investigators, vendors, contract research organizations, and members of other departments. The incumbent may supervise the activities of the Senior Medical Research Associate/Medical Research Associate(s). Duties and Responsibilities: 1. Takes major responsibility in operational activities inherent in planning, conduct, and completion of clinical trials. Estimates and orders clinical supplies. Establishes target dates for completion of assignments. Collects, reviews, and files clinical trial documentation. Prepares critical trial documents. Prepares for essential trial meetings. Develops screening rules with data management and Trial Clinical Monitor. Tracks and requests grant payments. Communicates with investigative sites on routine matters concerning on-going trials. Handles requests for trial related information. Prepares clinical trial budget with medical administration. Possible assignment as local clinical monitor under direction of appropriate supervisor. 2. Performs in-house review of clinical trial data to ensure completeness, accuracy, and consistency of trial data. Prepares data summaries. Ensures that all data discrepancies are resolved. Uses independent action and judgment during process. Seeks input on issues requiring medical judgment.3. Responsible for in-house management of investigative sites. Conducts telephone screens for potential sites.4. Assists Local and/or Trial Clinical Monitor in development of clinical trial protocol including interaction with outside consultants to discuss issues pertinent to design and implementation of such protocols. Provides substantial contribution to writing of clinical trial reports. Assists in preparation of IND/NDA annual reports. 5. Develops, implements, and continually reviews tracking systems for assigned projects to assure timelines are being met as anticipated.6. Liaison with members of other groups involved in drug development process, particularly data management and clinical field operations, and participates in Clinical Trial meetings.7. Reviews and organizes reconciliation of serious adverse event narratives.8. Serves as an important resource for Senior Medical Research Associate/Medical Research Associate(s) in their execution of trial tasks.9. Responsible for adhering to governmental regulations and company SOPs in conduct of clinical trials. Requirement: · College degree (e.g. B.S. Nursing, M.S., MPH, Pharm.D.) plus a minimum of 4 years experience in clinical research, preferably in the Pharmaceutical industry. · Advanced degree (e.g. Ph.D., M.D. from non US equivalent school) plus a minimum of 2 years experience in clinical research, preferably in the Pharmaceutical industry. · The incumbent must have thorough medical/scientific knowledge, analytical skills, knowledge of drug development and regulatory requirements, good oral and written communication skills, computer skills and ability to work as part of a team.
REQUIREMENTS:
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