Sr. Manager, CDM Consultant

W2 Contract

Salary Range: $166,400 - $187,200 per year

Location: Redwood City, CA - Remote Role

Job Summary:

The Clinical Data Management Consultant is responsible for all aspects of the data management (DM) process, from project planning to the development of project documentation, system set-up, UAT, and database lock. The core duties and responsibilities of the Consultant, CDM, are delineated below.

Duties and Responsibilities:

• Contributes to the technical infrastructure of CDM.
• Responsible for timelines and quality of deliverables.
• Provides feedback and task assignment to meet department and company objectives.
• Participates in the development, review, and implementation of departmental/company SOPs, templates, etc.
• Represents CDM in study team meetings.
• Oversight of CDM CRO/service providers.
• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines.
• Generates and/or reviews/approves study documents (e.g., study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions).
• Monitors the progress of all data management activities for the project to ensure project timelines are met.
• Executes and/or distributes data management metrics, listings, and reports, as required.
• Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed.
• Proactively identifies potential systemic and study issues/risks and recommends/implements solutions.
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial.
• Provide data management support to Statisticians and Statistical Programmers in the production of clinical trial reports.
• Perform duties as assigned by CDM management/Head of Department.

Requirements and Qualifications:

• Bachelor’s degree in Life Sciences, Computer Sciences, Mathematics, or a health-related field.
• 5-10 years of CDM experience in the pharmaceutical or biotechnology industry.
• CRO management experience.
• Prior oncology/hematology experience is highly desirable.
• Requires in-depth and hands-on knowledge of clinical data management principles, clinical trials process, and regulatory requirements.
• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
• Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversations, by telephone, and by email.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• Strong, well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint) and knowledge of industry standards (CDISC, SDTM, CDASH).
• Experience with web-based Electronic Data Capture (EDC) in particular Medidata RAVE, and industry wide thesauri, such as MedDRA and WHO Drug.
• Proven ability to work both independently with minimal supervision and in a dynamic team setting.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. 

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