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ID 365 Manager, Clinical Research Job
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| Employer Name: |
SpiderID: 2471830 |
| Location: Salt Lake City, Utah |
Date Posted: 9/5/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: 365 |
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Job Description:
Under general direction, plans, coordinates and executes function specific clinical
research programs for the clinical evaluation of products. Supervises assigned department staff.
Essential Job Functions:
Serve as Team Lead for the execution of assigned projects which includes, but is not limited to; resource allocation, timelines, quality of deliverables, and budget management. Communicate project timelines and priorities to all the multidisciplinary teams, and the status of task completion.
Coordinate day-to-day data management activities to ensure compliance with data management standards and the study protocol :
Oracle Clinical database design, builds, and study-specific validation prior to production. Serve as backup to perform design, builds, and validation when needed.
Case report form development (CRFs) and CRF completion guideline development, data entry and tracking.
Definition, development, and validation of edit check/data validation checks. Serve as backup to perform these functions as required.
Development and maintenance of study-specific Data Management Manuals including, but not limited to:
Evaluation of data received from external sources (e.g. Central Laboratory data) to ensure readiness for analysis.
Coordination of data transfer activities
Oversee or perform coding of medical terms.
Supervise data entry staff and clinical data specialists, as required and ensure staff compliance with existing SOPs and training materials
Implement newly developed DM SOPs or guidelines/standards to ensure consistent interpretation of data
Approve locking of databases and release of data subsets for analysis.
Engage in data management related systems validation.
Assist with data collection aspects of protocol development, as required.
Carries out managerial responsibilities in accordance with the organization's policies, procedures, state, federal and local laws.
Oversees, directs, coordinates and prioritizes the daily activities of assigned staff.
Establishes deadlines for conducting assigned tasks and assists in formulating an overall timetable for conducting clinical trials. Monitors progress of assigned tasks and instigates corrective action to met agreed deadlines.
Estimate resource needs and assists in developing budget projections. Interviews potential candidates for open positions and makes hiring recommendations.
Establishes performance standards for assigned activities and reviews output to ensure
standards are consistently met. Conducts performance evaluations for direct reports and assists direct reports with performance evaluation process.
rovides support, direction and coaching to assigned staff in areas of hiring, training,
disciplinary action, problem resolution, planning and work assignment delegation.
Ensures compliance with all applicable local, state, and federal regulations and guidelines regarding the conduct of clinical trials (cGCP)
Ensures compliance with all Company policies and procedures including safety rules and regulations.
Job Requirements:
Qualifications
Six (6) years pharmaceutical experience, including one (1) year in a supervisory or management capacity, or an equivalent combination of education and experience.
Knowledge of:
Pertinent Federal and State laws related to Pharmaceutical industry, Current FDA and Drug Enforcement Agency clinical requirements and cGMP's.
Clinical data management practices and procedures
Oracle clinical database structures and operation
Thorough knowledge of Oracle programming tools including SQL, SQL Plus, and PL/SQL.
Medical terminology and therapeutic agents
Current clinical research procedures and practices
Federal regulations and guidance concerning the conduct of clinical research including Good Clinical Practice (GCP)
Business, scientific and personal computer hardware and software applications.
Business English usage, spelling, grammar and punctuation.
Principles and practices of budget preparation and administration.
Administration, supervision and training practices and methods.
Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods.
Current Company policies, practices and procedures, including safety rules and regulations.
Skill in:
Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and/or techniques for resolution.
Creating, planning and implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
Responding to inquiries from management, employees and regulatory agencies.
Preparing, presenting and administering large, complex budgets and financial reports.
Communicating clearly and concisely, both orally and in writing.
Operating scientific and personal computers.
Managing multiple projects, duties and assignments.
Interpreting and applying Federal, state and local policies, procedures, laws and regulations.
Directing, coordinating, delegating assignments and reviewing the work of assigned department personnel.
Establishing and maintaining cooperative working relationships with others.
Education:
Bachelors degree in a scientific/technical or related field from an accredited college or university.
**Email resumes as attachemnt in word format
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required: 6
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: Camley Hitti |
Company Type: |
| Company: GRN of Utica |
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| City: Clinton |
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| State: New York |
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| Zip: 13323 |
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Web Site: http://www.grnutica.com
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