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.   

As the Senior Data Manager (Sr. DM) you will be a key member of the Data Management Team. Senior Data Managers serve as a key member of project teams, responsible for managing all data management tasks from project start-up to database lock, to producing a clean and analyzable database. The Sr. DM will work closely with the Manager and/or Director, Data Management to support the data management capabilities and processes within Catalyst to provide efficient data management to clinical study teams.

Position Responsibilities:

-Manages a Data Management project: 

• Provides/oversees DM services for multiple and/or complex clinical trials. 

• DM lead for internal/client team meetings and communications. 

• Produces and reviews metric reports for internal/external project teams. 

• 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 projections for data management activities. 

• Provides training of 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. 

• Works closely with 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. 

• Participates in bid defense meetings and sponsor presentations. 

-Clinical Data Query Review: 

• 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. 

• 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. 

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

-Oversees System Development and Modifications: 

• Drafts the CRF design, edits 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: 

• 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. 

• Develops Project Specific SOPs/WPs (as directed by PM or Director, DM). 

Position Qualifications:

Education: Bachelor’s degree in one of the life sciences, or equivalent knowledge and experience. 

Experience: 

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

• Extensive experience as a Lead Data Manager 

Required 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 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. 

• 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.) 

• Potential ability to travel for meetings or training activities. 

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.