Senior Clinical Data Manager

IDEAYA Biosciences • South San Francisco, CA

6d • Onsite

About The Position

IDEAYA is seeking a talented and highly motivated Senior Clinical Data Manager, Data Management (DM). This individual will be responsible for leading all aspects of the data management process from study start-up to study closure for IDEAYA’s late phase clinical program. As a Senior Clinical Data Manager, you will play a key role in ensuring complete, accurate and high-quality data collection for clinical trials. In addition, you will provide leadership within the organization to develop and improve clinical data management standards and processes. You should enjoy working with a dynamic and multi-disciplinary team and be able to work independently and collaboratively with key functions both internally and externally. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Requirements

• Bachelors in life sciences or related discipline with at least 8 years of experience in clinical data management
• Requires extensive knowledge of clinical data management principles, clinical trials process and regulatory requirements
• Strong verbal and written communication and critical thinking skills
• Experience with MedDRA and WhoDrug medical coding
• Excellent ability to manage competing priorities in a changing environment
• Strong working knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelines
• Proficient on EDC configuration and design, testing and validation, data collection and data review process, and data standardization
• Self-motivated and takes pride in your work
• Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships
• Attention to detail, ability to proactively identify issues and address with solutions-oriented approach
• All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct. Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels
• This position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

Nice To Haves

• Strong experience with late phase oncology trials is preferred
• Experience in Veeva CDMS system is a plus

Responsibilities

• Provide leadership for clinical data management function; ensure data management deliverables are completed on time, within budget and in accordance with quality standards and study requirements
• Responsible for leading end-to-end data management activities for late phase clinical trial(s); responsible for the oversight of CRO and/or DM vendors to ensure that project goals are achieved and overseeing adherence to scope of work and service agreements
• Represent data management in Study Management Team (SMT) meetings; proactively identify and communicate risks, suggest solutions and provide updates
• Establish and maintain strong relationships with cross-functional teams, vendors and key stakeholders for successful execution of clinical trial
• Collaborate with study statistician and statistical programmer to support production of clinical trial reports and other study deliverables
• Develop and maintain study-specific DM documents (e.g., electronic Case Report Form (eCRF) completion guidelines, annotated CRFs, CRF and data validation specifications, data transfer agreements, data management plan and data review plan)
• Lead and oversee Electronic Data Capture (EDC) build, modifications and deployment including creation and execution of User Acceptance Testing (UAT) plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., Interactive Response Technology (IRT)); develop and maintain EDC build/modification timelines
• Maintain study DM related documents for inspection readiness
• Develop data transfer agreements with external vendors
• Review and provide feedback on clinical documents (e.g., clinical protocols, statistical analysis plans, protocol deviation plans, vendor specifications)
• Report data management metrics and trends; proactively identify barriers to timely and successful trial execution and propose solutions
• Lead clinical data review of data listings, external data reconciliation reports, SAE reconciliation and implement data review strategy
• Serve as a subject matter expert on data management systems and processes
• Contributes to the development and improvement of data management standard operating procedures (SOPs) and document templates

Benefits

• Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval).
• Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 11-50 employees