Clinical Data Associate III (Lead CDA) - Raleigh-NC, Austin-TX or New Hope-PA

INC Research is currently seeking Clinical Data Associate III's (Lead CDA's) for our Raleigh-NC, Austin-TX and New Hope-PA offices. We offer an excellent benefits and PTO plan. Please read the job description below for more details about this exciting opportunity!

 

 

Imagine Waking Up Each Morning Excited About Your Career!

INC Research was recently recognized as one of the fastest growing private companies in the region at Triangle Business Journal's annual Fast 50 Awards ceremony on November 1, 2007, ranking 4th on the list of 50. We continue our strong growth and take pride in the solid reputation we've built within the drug development industry. With Raleigh as our global headquarters, we now have 24 offices worldwide.

At INC Research we provide therapeutically focused drug development services through our Trusted Processâ„¢, a proven, metrics-driven methodology, with a total focus on meeting or exceeding client expectations throughout a project life cycle. Our ability to meet this objective is directly related to the quality and dedication of our staff, and their commitment to this company-wide philosophy.

It is by continually attracting the industry's most talented individuals that INC Research has emerged as a leading global CRO. Our high percentage of repeat business from customers is a testament to the quality and dedication of our INC Research team. If you'd like to be a member of this top-notch team, contact us today.

 

POSITION SUMMARY:

 

Using a strong knowledge of databases, user testing, and systems specifications, manages the data in a clinical study database and system.  Performs Clinical Data Management (CDM) review of all study subject information captured during the conduct of a clinical study.  Works on a project team and 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 Signs time off requests and timesheetsPerforms performance reviews, coaching, and disciplinary actions along with Group Manager/Data Management Team Leader

 Technical

 

1.  Develops and implements study-specific Clinical Data Management Plans which meet sponsor specifications.

 

2.  Functions as a study Lead Data Manager on small to medium size studies or co-lead on clinical data management programs.

 

3.  Provides project specific training and updates study team training records.

 

4.  Develops database specifications (e.g., annotates Case Report Forms) and specifications for external data sources.

 

5.  Writes user test plans for data entry screen, electronic edit checks and medical coding.

 

6.  Performs User Testing and analysis of electronic edit checks and medical coding.

 

7.  Writes functional specification for electronic edit checks, quality control listings and non-standard clinical study data reports.

 

8.  Ensures that all clinical study data captured and maintained by external vendors are incorporated into the study database in collaboration with Clinical Programming.  Identifies and corrects discrepancies between the clinical database and data merged into the database from external sources.

 

9.  Performs medical data encoding as specified in study-specific Coding Plans and the study protocol. 

 

 

10. Uses strong working knowledge of clinical database design and structure to facilitate data review activities and create corrective action plans.

 

11. May perform CDA I and II duties as needed.

 Project Management

 

12. Runs, reviews and distributes reports to internal study team and sponsors.

 

13. Creates data management timelines with project team based on productivity standards and sponsor expectations.

 

14. Tracks data processing progress and communicates problems/backlogs to project team and management.

 

15. Maintains an awareness of the project scope of work and notifies senior management of all sponsor requests that are outside current scope in accordance with relevant SOPs/WIs

 

16. Provides realistic team goals on a regular basis.

 

17. Defines expectations, roles and responsibilities of data management team members.

 

18. Calculates and monitors productivity on studies.

 

19. May participate and lead the development of departmental processes, procedures, and departmental and company wide training programs.

 

20. May participate and lead in the implementation of new technologies and services.

 

21. May present data management processes during pre-award meetings with potential sponsors.

 

22. Attends Investigator Meetings and presents data management functions.

 

 

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 3 years directly related data management experience, or AA/AS and 4 years of health care or clinical research experience with 3 years directly related data management experience or equivalent combination of education and experience that provide the skills and knowledge necessary to perform the job.

 

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 multi-task under deadlines, and work as part of a multi-disciplinary team as well as independently.  Ability to be flexible and adapt to change.  Some travel may be required .