Senior Clinical Data Manager

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team you will join other outstanding quality professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

Opportunity :

The Senior Clinical Data Manager is responsible for all 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 fundamental knowledge of the data management process and can plan manage and coordinate all Data Management activities for assigned study(ies) with minimal guidance. This person may have project level oversight 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 when 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 oversight 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 ad hoc and scheduled data listing review and generates / resolves queries in EDC.

Performs external data reconciliation against EDC.

Performs Serious AE reconciliation according to SOPs and guidelines as applicable.

Executes and / or distributes data management metrics listings and reports.

Provides oversight of data management CRO / service providers including manages and monitors the progress 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 EDC system and / or CRF completion guidelines and EDC system to internal or external study team members as needed.

Proactively identifies potential study issues / risks and recommends / implements solutions.

Maintains study DM related 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 :

Bachelors degree in health sciences Life Sciences Mathematics Computer Sciences or health-related field.

At least five (5) years for Sr. CDM of Data Management experience in the pharmaceutical or biotechnology industry depth and exposure to DM related 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 (EDC systems MS Word Excel PowerPoint).

Knowledge of industry standards (CDISC SDTM CDASH).

Experience with web-based Electronic Data Capture (EDC) 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 :

Bachelors degree in health sciences Life Sciences or health-related field

CRO / Service provider management experience.

Prior oncology / solid tumor experience highly desired

Knowledge of industry standards (CDISC SDTM CDASH).

Working knowledge of statistical programming packages (e.g. SAS) is a plus

The base salary range for this full-time position is $138000 to $172000 for candidates working onsite at our headquarters in Redwood City CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role level and location. Individual pay is determined by multiple factors including job-related skills experience market dynamics and relevant education or training.

Please note that base salary 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.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity / expression national origin / ancestry age disability marital status medical condition and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when 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 additional information please contact

#LI-Hybrid #LI-JC1

Required Experience :

Manager

Key Skills

SQL,Data Collection,GCP,Master Data Management,R,Data Management,Clinical Trials,User Acceptance Testing,Data Warehouse,SAS,Oracle,Data Analysis Skills

Employment Type : Full Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 138000 - 172000