Senior Clinical Data Manager

Revolution Medicines; Redwood City (CA); On-site; USD 158,000 - 198,000; Full time

Job summary

Join a pioneering firm in precision oncology as a Senior Clinical Data Manager, where your expertise will drive the management of clinical trial data. In this pivotal role, you will oversee all aspects of data management, from project documentation to database lock, ensuring compliance with regulatory standards and contributing to innovative cancer therapies. Collaborate with a talented team, manage timelines, and provide critical insights that shape the future of oncology treatments. This is not just a job; it's an opportunity to make a significant impact in the fight against cancer while advancing your career in a supportive and dynamic environment.

Benefits

Competitive cash compensation

Robust equity awards

Strong benefits

Learning and development opportunities

Qualifications

• 3+ years of Data Management experience in pharma or biotech.
• Solid knowledge of clinical data management principles and regulations.

Responsibilities

• Manage data management timelines and deliverables for clinical trials.
• Generate and review study documents and provide data management updates.

Skills

Data Management

Clinical Trials Process

Regulatory Requirements

Technical Skills (EDC, MS Office)

Interpersonal Skills

Project Management

Problem-Solving

Education

Bachelor's in Health Sciences

Bachelor's in Life Sciences

Bachelor's in Mathematics

Bachelor's in Computer Sciences

Tools

Electronic Data Capture (EDC)

MS Word

MS Excel

MS PowerPoint

SAS

Job description

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s 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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The 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:

1. Representing data management in study team meetings, able to facilitate and provide data management updates and/or input when appropriate.
2. Managing data management timelines to coordinate and synchronize deliverables with the overall study timelines.
3. Generating and/or reviewing/approving 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).
4. Reviewing protocols for appropriate data capture including electronic Case Report Form (eCRF) design and external data vendors’ systems.
5. Providing oversight of database set-up/migrations/updates including coordinating and performing UAT.
6. Leading the development of internal Data Review Plan and coordinating cross functional team data listing review.
7. Coordinating the internal medical coding review.
8. Performing ad hoc and scheduled data listing review and generates/resolves queries in EDC.
9. Performing Serious AE reconciliation according to SOPs and guidelines, as applicable.
10. Executing and/or distributing data management metrics, listings, and reports.
11. Providing oversight of data management CRO/service providers including managing and monitoring the progress of data management activities with CROs and/or other service providers on assigned studies; building effective relationships with CRO/service provider counterparts.
12. Reviewing and providing feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications.
13. Providing training on the EDC system and/or CRF completion guidelines and EDC system to internal or external study team members, as needed.
14. Proactively identifying potential study issues/risks and recommending/implementing solutions.
15. Maintaining study DM related documents/files for inspection readiness.
16. Providing DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
17. Assisting with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies).
18. Participating in CRO/vendor selection process for outsourced activities.
19. Supporting budget and resource planning across assigned projects.
20. Participating in the development, review and implementation of departmental SOPs, templates, and processes.
21. Participating in department or cross-functional initiatives (as needed).
22. Contributing to a professional working environment through exemplifying RevMed Core Values.

Required Experience, Skills, and Education:

1. Bachelor’s degree in health sciences, Life Sciences, Mathematics, Computer Sciences, or health-related field.
2. At least three years for CDM and five 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.
3. Solid knowledge of clinical data management principles, clinical trials process and regulatory requirements.
4. Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
5. Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).
6. Knowledge of industry standards (CDISC, SDTM, CDASH).
7. Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
8. Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
9. Ability to handle multiple projects and prioritize effectively, well organized and detail oriented.
10. Proven ability to work both independently and in a team setting.

Preferred Skills:

1. Prior oncology/solid tumor experience highly desired.
2. Working knowledge of statistical programming packages (e.g. SAS) is a plus.

The base salary range for this full-time position is $158,000 to $198,000 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.