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 reputed company duties and responsibilities of the Sr/CDM are delineated below. Specifically, you will be responsible for:

• Represents data management in study team meetings, reputed company to facilitate and reputed company 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 reputed company (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 reputed company.
• 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 reputed company working environment through exemplifying RevMed reputed company 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 reputed company-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 reputed company and prioritize effectively, reputed company organized and detail oriented.
• Proven ability to work both independently and in reputed company 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 reputed company for this full-time position for candidates working onsite at our reputed company in Redwood reputed company, CA is listed below. The reputed company displayed on reputed company job posting is intended to be the reputed company pay salary reputed company for an individual working onsite in Redwood reputed company 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 reputed company 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, reputed company, religion, gender, sexual orientation, gender identity/reputed company, 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 reputed company 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 reputed company to us in accordance with our CCPA Notice and reputed company Policy. For additional information, please contact reputed company@revmed.com. reputed company Pay Salary reputed company $138,000-$172,000 USD Apply tot his job Apply To this Job