QuintilesIMS Senior Lead Data Manager (Office or Home Based) - Novella Clinical in Raleigh, North Carolina

Description:

Senior Lead Clinical Data Manager position is to manage all data management tasks for a program of studies from study start-up to database lock, to produce a clean and analyzable database.

ESSENTIAL JOB FUNCTIONS,DUTIES AND RESPONSIBILITIES:

· Manages DM Projects/Programs

Ø DM lead for internal/client team meetings and communication

Ø Provides Metric reports for internal/external project teams

Ø Provides staffing projections for DM activities for studies

Ø Implements process or system improvements for global implementation

Ø Ownership for project deliverables within Data Management scope of services

Ø Discusses roadblocks with PM & principal for completing study objectives in a timely manner

Ø Reviews project budgets and staffing projections for data operation activities

Ø Provides training of other DM staff on project specific processes

· Clinical Data and Query Review:

Ø Creates Data Review Plan for studies and develops standards for the Department

Ø Creates listings using ad hoc query tools

Ø Oversees the issuing of queries and review query responses with the highest level of quality based upon the Data Review Plan

· Oversees System Development and Modifications:

Ø Drafts the CRF design, edit check specification and DM listings

Ø Facilitates clinical team review of system (eCRFs, Edit Checks, and Data Review Plan, etc.)

Ø Documents comments from internal and sponsors for discussion and approval

Ø Ensures all non-DM activities related to database development are completed in a timely manner

Ø Ensures all database modifications are communicated with team and implemented effectively

· Validation Creation

Ø Oversees the entry of data in the Development or Quality Control systems used for validation.

Ø Assists with the validation of CRF system (CRF content & edit checks), Reports using EDC Reporting and/or J-Review, and associated change control.

Ø Provides feedback to other project team members and managers to improve the deliverables.

· Creates and Maintains Documentation for studies/programs/departmental standards:

Ø DMP (along with supporting DM documents), CRF Completion guidelines, Trial Design Document, Edit specifications, Reconciliation guidelines, Report specifications

Ø Project Specific SOPs/WPs (as directed by PM) or Department Forms/Templates for SOPs/WPs

KNOWLEDGE, SKILLS ANDABILITIES:

· Ability to lead DM team members and work well with technical and clinical team members

· Ability to collaborate with entire clinical team (CRAs, Safety, Biostatisticians, etc) and answer questions related to specific data collection concerns

· Ability to maintain positive and open relations with internal, sponsor, and vendor team members

· Ability to facilitate team meetings ensuring accurate attendees and take meeting minutes

· Excellent knowledge of clinical trials data processing concepts

· Ability to perform research for data collection and protocol specific topics

· Proficiency with multiple DBMS processing systems (preferred systems are InForm and Rave)

· Proficiency with Novella SOPs and WPs

· Organized and thorough with attention to details

· Effective Interpersonal skills and excellent communications skills, verbal, written and listening

· Ability to learn new things and teach others

· Ability to accept constructive criticism

· Effective logical thinking ability in regards to Problem-solving skills

· Proficiency in computer programs or time management tools (Excel, Word, @Task, MSProject, etc.)

CRITICAL JOB FUNCTIONSIN ACCORDANCE WITH ADACRITERIA:

· Very little physical effort required to perform normal job duties (unless otherwise indicated)

· Travel, occasional as required for bid defenses, Investigator Meetings, or other meetings as requested, not anticipated to exceed 80hr per year.

MINIMUM RECRUITMENTSTANDARDS:

· Bachelor's degree in one of the life sciences, or equivalent knowledge and experience, and

· 7 years of experience in pharmaceutical industry and/or contract research organization, with 5 years in data management, and

· 2 years as a Lead Data Manager.

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

Qualifications:

MINIMUM RECRUITMENT STANDARDS:

· Bachelor's degree in one of the life sciences, or equivalent knowledge and experience, and

· 7 years of experience in pharmaceutical industry and/or contract research organization, with 5 years in data management, and

· 2 years as a Lead Data Manager.

Primary Location:

USA-North Carolina-Research Triangle Park

Other Location(s):

USA-North Carolina-Raleigh, USA-Ohio-Columbus, USA-North Carolina-Durham