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Catalyst Clinical Research · 12 hours ago

Senior Data Manager

United States

Full-time

Remote

Senior Level

7+ years exp

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries. As the Senior Data Manager, you will manage all data management tasks from project start-up to database lock, ensuring the production of a clean and analyzable database.

Pharmaceutical

No H1B

Responsibilities

Manages a Data Management project: • Provides/oversees DM services for multiple and/or complex clinical trials

Serves as DM lead (LDM) for internal/client team meetings and communications

Produces and reviews metric reports for internal/external project teams

Has ownership of 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 needs for data management activities, including providing input into project forecasts and achieved milestones/units

Identifies and manages activities outside of the scope of services for assigned projects

Provides training for other DM staff on project specific processes

Ensures adherence to GCP, regulatory guidelines and standard operating procedures

Manages database lock, transfer and CRF archiving for assigned projects

Manages client relationships

Creates the Data Quality Review Plan and coordinates cross-functional input from project team

Defines the DM listings using ad hoc query tools

Reviews clinical and external vendor data to ensure a high degree of quality

Performs data review. Issues queries and reviews 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

Manages the processing of local laboratory data for studies and addresses inconsistencies with sites and CRAs as applicable

May assist in review of subject validity/population adjudication

Monitors data quality and integrity, ensuring compliance with company and regulatory standards

Drafts the CRF design, edits check specification and DM listings specifications

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

Oversees and performs the validation of CRF system (CRF content & edit checks), reports using EDC Reporting, and associated change control requests

Provides feedback to the other project team members and managers to improve the deliverables

Develops study-specific Data Management Plan along with supporting DM documents, such as CRF Completion 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

Develops Project Specific SOPs/Work Instructions (Wis) (as directed by PM or Director, DM)

Works closely with a wide range of clients and internal colleagues on behalf of the business and supports the bid defense process

May support regulatory and sponsor audits, as required

Qualification

Clinical data managementLead Data Manager experienceEDC systems proficiencyClinical PracticesCDISC standards familiarityTime management toolsTeam playerFacilitation skillsOrganizational skillsAttention to detailPresentation skillsInterpersonal skillsProblem-solving skills

Required

Bachelor's degree in related field, or equivalent knowledge and experience

Seven plus years of clinical data management experience in pharmaceutical industry and/or contract research organization

Extensive experience as a Lead Data Manager

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 data processing systems (EDC systems, preferably RAVE)

Proficiency with Catalyst SOPs, WPs for general and DM operations

Solid understanding of Good Clinical Practices and relevant regulatory guidelines

Familiarity with CDISC standards

Efficient with organizational skills to meet deadlines

Organized and thorough with attention to detail

Excellent presentation skills

Effective interpersonal skills and excellent communications skills, verbal, written and listening

Ability to accept constructive criticism

Effective logical thinking ability regarding problem-solving skills

Proficiency in computer applications and time management tools (Excel, Word, Outlook, Project, etc.)

Ability to travel for meetings or training activities