Pharmaceutical Jobs - Clinical Research Jobs

Position

Manager, Clinical Data Management-US-Raleigh

Company

INC Research

Location

Raleigh

Country

United States

Job Description

Manager, Clinical Data Management

Job Code(s): MDM1109BA
Location(s): US - North Carolina, Raleigh
Region(s): North America
Date Posted: 11/04/2009

INC Research is currently seeking experienced candidates for our Manager, Clinical Data Management position based at our corporate headquarters in Raleigh, NC. The Manager, Clinical Data Management, supports the work of the Clinical Data Associates/Lead Data Managers. Mentoring, developing training plans, and project support are among those duties. Using a strong knowledge clinical data management, oversees all data management aspects of multiple studies, including study documentation, timelines and staffing to ensure data integrity. Interacts with study sponsors on a regular basis to maintain positive relationships. Complies with all Standard Operating Procedures (SOPs)/ Work Instructions (WIs), regulatory guidelines and directives, and study specific plans pertaining to collection, review and management of clinical study data. ESSENTIAL JOB FUNCTIONS: Administrative Management Mentors, motivates and supervises data management staff , including Lead Data Managers Signs time off requests and timesheets Performs performance reviews, coaching, and disciplinary actions Maintains staff awareness of evolving working practices/policies/work instructions Monitors productivity and quality of data management staff Assigns tasks to team members, based on ability, and at their discretion Technical 1. May function as a Lead Data Manager on one or more studies. Project Management 2. Represents data management in project related cross-functional study team meetings. 3. Manages sponsor relationships for all studies assigned. 4. Holds regular data management team meetings to communicate study information. 5. Performs cross-functional communications where issues are judged to need clarification and /or resolution. 6. Provides and manages projections and actual project budgets for assigned studies under the guidance of the Group Manager/Director. 7. May provide support to Business Development staff by participating in presentations to sponsors. 8. Participates and may lead in the development of departmental processes, work instructions, and standard operating procedures. 9. Participates and may lead in the development of departmental and company wide training programs. 10. Participates and may lead in the implementation of new technologies and services. 11. Performs Clinical Data Associate duties as needed. OTHER DUTIES: Performs other work related duties as assigned. Moderate travel may be required (up to 25%). EDUCATIONAL/SKILL/EXPERIENCE REQUIREMENTS: Requires a minimum of a B.S./B.A. degree in the biological sciences or related disciplines in the natural science/health care field or equivalent plus a minimum of 5 years directly related data management experience, or AA/AS and 7 years of health care or clinical research experience with 5 years directly related data management experience or equivalent combination of education and experience that provide the skills and knowledge necessary to perform the job. Some experience supervising staff is desired. Advanced degree is preferred but not required. Solid judgment and tactful discretion are required. Working knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices is required. Requires effective oral and written communication skills, presentation skills, and attention to detail. Experience with relational database management software systems is required. Requires proficiency in Word, Excel, and Email. Ability to multitask under deadlines, and work as part of a multidisciplinary team as well as independently. Ability to be flexible and adapt to change.

At INC Research, It's "All About the Process"

For more than two decades, INC Research has been a therapeutically focused contract research organization with an unrivaled reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I - Phase IV programs in therapeutic areas of specialty, and in innovative pediatric trials. Our Trusted Process™ methodology and therapeutic foresight leads our customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, North Carolina, and has a presence in 40 locations worldwide.

INC Research is pleased to offer our employees a comprehensive benefits plan that includes: Healthcare Coverage (Medical/Dental/Vision), Flexible Spending Accounts, 401(k), Life Insurance and AD&D, Short- and Long-Term Disability, Supplemental Income Protection, Employee Assistance Program, Paid Time Off and Paid Holidays.

We offer a competitive salary and comprehensive benefits package. For immediate consideration, please email your CV with salary requirements to: (Email submissions preferred.)

Company Profile

INC Research is a therapeutically focused global contract research organization (CRO) with unrivaled expertise and a reputation for conducting global clinical development programs of the highest integrity. INC Research has a deep-rooted history of therapeutic expertise and technological innovation. Founded more than two decades ago as an academic research organization focused on CNS research, we've translated that expertise into a global organization with the added specialties of infectious diseases, oncology and pediatrics, as well as full data services capabilities.

Job Type

Full Time

Salary

Upto 0 $ Per Month

Skills Required

Clinical Data Management

Reference

MDM1109BA

Posted On

24 November 2009

Last Date to Apply

25 December 2009

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