IQVIA Senior Lead Clinical Data Manager (Contract, Home/Office-Based) - Novella Clinical in Morrisville, 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.

ESSENTIALJOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Manages DM Projects/Programs

  • DM lead for internal/clientteam meetings and communication

  • Provides Metric reports forinternal/external project teams

  • Provides staffing projectionsfor DM activities for studies

  • Implements process or systemimprovements for global implementation

  • Ownership for projectdeliverables within Data Management scope of services

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

  • Reviews project budgets andstaffing projections for data operation activities

  • Provides training of other DMstaff on project specific processes

  • Clinical Data and Query Review:

  • Creates Data Review Plan forstudies and develops standards for the Department

  • Creates listings using ad hocquery tools

  • Oversees the issuing ofqueries and review query responses with the highest level of qualitybased upon the Data Review Plan

  • Oversees System Development andModifications:

  • Drafts the CRF design, editcheck specification and DM listings

  • Facilitates clinical teamreview of system (eCRFs, Edit Checks, and Data Review Plan, etc.)

  • Documents comments frominternal team and sponsors for discussion and approval

  • Ensures all non-DM activitiesrelated to database development are completed in a timely manner

  • Ensures all databasemodifications are communicated with team and implemented effectively

  • Validation Creation

  • Oversees the entry of data inthe Development or Quality Control systems used for validation.

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

  • Provides feedback to otherproject team members and managers to improve the deliverables.

  • Createsand Maintains Documentation for studies/programs/departmental standards:

  • DMP (along with supporting DMdocuments), CRF Completion guidelines, Trial Design Document, Editspecifications, Reconciliation guidelines, Report specifications

  • Project Specific SOPs/WPs (asdirected by PM) or Department Forms/Templates for SOPs/WPs

KNOWLEDGE,SKILLS AND ABILITIES:

  • Abilityto lead DM team members and work well with technical and clinical teammembers

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

  • Abilityto maintain positive and open relations with internal, sponsor, and vendorteam members

  • Abilityto facilitate team meetings ensuring accurate attendees and take meeting minutes

  • Excellentknowledge of clinical trials data processing concepts

  • Abilityto perform research for data collection and protocol specific topics

  • Proficiencywith multiple DBMS processing systems (preferred systems are InForm andRave)

  • Proficiencywith Novella SOPs and WPs

  • Organizedand thorough with attention to details

  • EffectiveInterpersonal skills and excellent communications skills, verbal, writtenand listening

  • Abilityto learn new things and teach others

  • Abilityto accept constructive criticism

  • Effectivelogical thinking ability in regards to Problem-solving skills

  • Proficiencyin computer programs or time management tools (Excel, Word, @Task,MSProject, etc.)

CRITICALJOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very little physical effortrequired to perform normal job duties (unless otherwise indicated)

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

MINIMUMRECRUITMENT STANDARDS:

  • Bachelor'sdegree in one of the life sciences, or equivalent knowledge andexperience, and

  • 7years of experience in pharmaceutical industry and/or contract researchorganization, with 5 years in data management, and

  • 2years 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:

EEO Minorities/Females/Protected Veterans/Disabled

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-Morrisville