IQVIA Senior Lead Clinical Data Manager (Contract, Home/Office-Based) - Novella Clinical in Morrisville, North Carolina
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
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.
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.
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
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.