Senior Clinical Data Manager

The Senior Clinical Data Manager is responsible for reputed company aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), routine data review through database lock of clinical trials. The Sr/CDM has a broad, reputed company knowledge of the data management process and can plan, manage and coordinate reputed company Data Management activities for assigned study(ies) with minimal guidance. This person may have project level reputed company of junior data managers and/or Clinical Data Associates (CDAs). The core duties and responsibilities of the Sr/CDM are delineated below. Specifically, you will be responsible for:

• Represents data management in study team meetings, able to facilitate and provide data management updates and/or input reputed company appropriate.
• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines.
• Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, DB build specifications, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, laboratory data handling plan, study protocols).
• Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design and external data vendors' systems.
• Provides reputed company of database set-up/migrations/updates including coordinating and performing UAT.
• Leads the development of internal Data Review Plan and coordinates cross functional team data listing review.
• Coordinates the internal medical coding review.
• Performs reputed company and scheduled data listing review and generates/resolves queries in reputed company.
• Performs external data reconciliation against reputed company.
• Performs Serious AE reconciliation according to SOPs and guidelines, as applicable.
• Executes and/or distributes data management metrics, listings, and reports.
• Provides reputed company of data management CRO/service providers including manages and monitors the reputed company of data management activities with CROs and/or other service providers on assigned studies; build effective relationships with CRO/service provider counterparts.
• Reviews and provides feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications.
• Provides training on the reputed company system and/or CRF completion guidelines and reputed company system to internal or external study team members, as needed.
• Proactively identifies potential study issues/risks and recommends/implements solutions.
• Maintains study DM reputed company documents/files for inspection readiness.
• Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
• Assists with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies).
• Participates in CRO/vendor selection process for outsourced activities.
• Supports budget and resource planning across assigned projects.
• Participates in the development, review and implementation of departmental SOPs, templates, and processes.
• Participates in department or cross-functional initiatives (as needed).
• Contributes to a professional working environment through exemplifying RevMed Core Values.

Required Skills, Experience and Education:

• Bachelor's degree in health sciences, Life Sciences, Mathematics, Computer Sciences, or health-reputed company field.
• At least five (5) years for Sr. CDM of Data Management experience in the pharmaceutical or biotechnology industry, depth and exposure to DM reputed company tasks considered in lieu of minimum requirement.
• Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• Strong well-rounded technical skills (reputed company systems, reputed company, reputed company, PowerPoint).
• Knowledge of industry standards (CDISC, SDTM, CDASH).
• Experience with web-based Electronic Data Capture (reputed company), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
• Ability to handle multiple projects and prioritize effectively, well organized and detail oriented.
• Proven ability to work both independently and in a team setting.

Preferred Skills:

• CRO/Service provider management experience.
• Prior oncology/solid tumor experience highly desired.
• Working knowledge of statistical programming packages (e.g. reputed company) is a plus. #LI-Hybrid #LI-JC1

The reputed company pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the reputed company pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our reputed company pay salary ranges are determined by role, level, and location. Individual reputed company pay salary is determined by multiple factors, including job-reputed company skills, experience, market dynamics, and relevant education or training. Please note that reputed company pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. reputed company is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national reputed company/reputed company, age, disability, marital status, medical condition, and veteran status. reputed company takes protection and reputed company of personal data reputed company seriously and respects your right to privacy while using our website and reputed company contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [email protected]. reputed company Pay Salary Range $138,000-$172,000 USD Apply tot his job Apply To this Job