Lead Clinical Data Manager position is to manage all data management tasks from study start-up to database lock, to produce a clean and analyzable database.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
· Manages a data management project
Ø DM lead for internal/client team meetings and communication
Ø Produces and Reviews Metric reports for internal/external project team
Ø Implements process or system improvements
Ø Ownership for project deliverables within DM and Project Programming scope of services
Ø Provides staffing projections for all DM activities (including coding)
Ø Discusses roadblocks with PM & Principal DM for completing study objectives in a timely manner
Ø Reviews project budgets and staffing projections for data management activities
Ø Provides training of other DM staff on project specific processes
· Clinical Data and Query Review
Ø Creates the Data Review Plan and the DM listings using ad hoc query tools
Ø Issues queries and review query responses with the highest level of quality based upon the Data Review Plan, Aggregate Checks (DM listings), Reconciliation (LAB, SAE, ECG), other reviewers (Biostatistician, Medical Monitor, Client), and ad hoc reports
· Oversees System Development and modifications:
Ø Drafts the CRF design, edit check specification and DM listings
Ø Facilitates clinical team review of system documents (CRFs, Edit Checks, Data Review Plan, etc)
Ø Consolidates comments from internal/sponsor for discussion and approval
Ø Ensures all non-DM activities related to database development are completed in a timely manner
Ø Manages all database modifications for DM activities.
· Validation Creation:
Ø Oversees the entry of data in the Development or QC systems that will be used for validation.
Ø Performs the validation of CRF system (CRF content & edit checks), Reports using EDC Reporting and/or J-Review, and associated change control requests.
Ø Provides feedback to the other study team members and management to improve the deliverables.
· Creates and Maintains Documentation for the study
Ø Data Management Plan along with supporting DM documents, such as CRF Completion guidelines, Data Entry guidelines, Trial Design Document, Edit specifications, Reconciliation guidelines, and Report specifications.
Ø Project Specific SOPs/WPs (as directed by PM)
KNOWLEDGE, SKILLS AND ABILITIES:
· Team player with ability to learn new things and teach others
· Ability to work well with technical and clinical team members and collaborate with entire clinical team (CRAs, Safety, Bios, etc) and maintain positive and open relations with internal, sponsor, and vendor team members
· Ability to facilitate team meetings
· Knowledge of clinical trials concepts
· Ability to create detailed DM study instructions and documents (CRF guidelines, trial design document, edit check specifications, data review plan, etc.)
· Proficiency with DBMS processing systems (preferred systems are InForm, Rave, and Oracle Clinical)
· Proficiency with Novella SOPs, WPs for general and DM operations
· Efficient with organizational skills to meet deadlines
· Organized and thorough with attention to details
· Effective interpersonal skills and excellent communications skills, verbal, written and listening
· Ability to accept constructive criticism
· Effective logical thinking ability in regards to Problem-solving skills
· Proficiency in computer applications and time management tools (Excel, Word, Outlook, Project, etc.)
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
· Very little physical effort required to perform normal job duties (unless otherwise indicated)
MINIMUM RECRUITMENT STANDARDS:
· Bachelor's degree in one of the life sciences, or equivalent knowledge and experience, and
· 3 years of experience in pharmaceutical industry and/or contract research organization, with 2 years in data management.