Senior Clinical Data Manager
Company: Catalyst Clinical Research LLC
Location: Raleigh
Posted on: March 18, 2023
Job Description:
Catalyst Clinical Research is a niche provider of clinical
research services through two established solutions- Catalyst Flex
and Catalyst Oncology. Here at Catalyst Clinical Research we
provide support and services exclusively to biotech companies
because we know and understand the biotech environment. Our 15+
years of experience allow us to quickly grasp the evolving needs of
our clients so we can deliver the solutions essential to meet the
evolving needs and unexpected changes inherent in oncology
development. When protocols amend or emerging data suggest a
breakthrough straight from Phase I to registration, we are
ready.Position Summary: - As a Senior Data Manager you will be a
key member of the Development Operations, Data Management Team. You
will serve as a key member of project teams, responsible for
managing all data management tasks from project start-up to
database lock, to produce a clean and analyzable database.Position
Accountabilities/Responsibilities: -Manages a Data Management
project: -
DM lead for internal/client team
meetings and communication.Produces and reviews metric reports for
internal/external project team.Ownership for project deliverables
within DM scope of services, including projections.Discusses
roadblocks and solutions for completing project objectives in a
timely manner.Reviews project budgets and staffing projections for
data management activities.Provides training of other DM staff on
project specific processes.-Clinical Data Query Review: -
Creates the Data Review
Specifications and the DM listings using ad hoc query tools.Issues
queries and reviews query responses with the highest level of
quality based upon the Data Review Specifications, Aggregate Checks
(DM listings), Reconciliations (LAB, SAE, ECG), other reviewers
(Biostatistician, Medical Monitor, Client), and ad hoc
reports.Coordinates medical coding activities.-Oversees System
Development and Modifications: -
Drafts the CRF design, edit check
specification and DM listings.Facilitates clinical team review of
system documents (CRFs, Edit Checks, Data Review Plan,
etc.)Consolidates comments from internal team/sponsor for
discussion and approval.Ensures all non-DM activities related to
database development are completed in a timely manner.Manages all
database modifications for DM activities.-Validation Creation: -
Oversees the entry of data in the
development or QC systems that will be used for validation.Assists
with the validation of CRF system (CRF content & edit checks),
reports using EDC Reporting and/or J-Review, and associated change
control requests.Provides feedback to the other project team
members and managers to improve the deliverables.-Creates and
maintains documentation for the project: -
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.Project
Specific SOPs/WPs (as directed by PM).Supervisory
Requirements/Responsibilities: - N/APosition Qualifications and
Requirements: - Education: - Bachelor's degree in one of the life
sciences, or equivalent knowledge and experience. -Experience: -
7 years of clinical data management
experience in pharmaceutical industry and/or contract research
organization. - - -Extensive experience as a Lead Data Manager in
Oncology and Hepatology trials.Required Certifications: -
N/ARequired Skills: -
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 project instructions and
documents (CRF guidelines, trial design document, edit check
specifications, data review plan, etc.)Proficiency with DBMS
processing systems (preferred systems are Rave and
Medrio).Proficiency with Catalyst 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 regard
to problem-solving skills.Proficiency in computer applications and
time management tools (Excel, Word, Outlook, Project,
etc.)Potential ability to travel for meetings or training
activities.Working Conditions: - ---Sedentary work that primarily
involves sitting/standing. -Catalyst Clinical Research, LLC is an
equal opportunity employer. We celebrate diversity and are
committed to creating an inclusive environment for all
employees.Powered by JazzHR
Keywords: Catalyst Clinical Research LLC, Raleigh , Senior Clinical Data Manager, Executive , Raleigh, North Carolina
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