Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.
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As a Senior Data Manager, you will be a key member of the Clinical 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 :
- DM lead for internal / client team meetings and communication.
- Produces and reviews metric reports for internal / external project teams.
- Ownership of project deliverables within DM scope of services.
- Discusses roadblocks and solutions for completing project objectives in a timely manner.
- Assists in reviewing project budgets and staffing projections for data management activities.
- Provides training of other DM staff on project-specific processes.
Clinical Data and Query Review :
Creates the Data Review Specifications and the DM listings using ad hoc query tools.Reviews clinical and external vendor data to ensure a high degree of quality.Issues queries and reviews query responses 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 Modifications :
Drafts the CRF design specification, 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 :
Assists with and / or performs the validation of CRF system (CRF content & edit checks), reports using EDC Reporting and / or J-Review, and associated change control requests.Creates and maintains documentation for the project :
Develops study-specific 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.Provides and / or maintains relevant data management documentation for filing in the Trial Master File.Supervisory Requirements / Responsibilities : N / A
Position Qualifications and Requirements :
Education : Bachelor’s degree in one of the life sciences, or equivalent knowledge and experience.
Experience :
4 years of clinical data management experience in the pharmaceutical industry and / or contract research organization.Experience as a Lead Data Manager in Oncology and Hepatology trials.Required Certifications : N / A
Required Skills :
Team player with the ability to learn new things and mentor others.Ability to work well with technical and clinical team members and collaborate with the 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 trial concepts.Ability to create detailed DM project instructions and documents (CRF guidelines, trial design document, edit check specifications, data review plan, etc.).Proficiency with data processing systems (preferably Rave and / or Medrio).Proficiency with Catalyst SOPs, WPs for general and DM operations.Efficient with organizational skills to meet deadlines.Organized and thorough with attention to detail.Effective interpersonal skills and excellent communication 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.).Ability to travel frequently for meetings or training activities may be required.Working Conditions : Sedentary work that primarily involves sitting / standing. This can be a remote or office-based role.
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