Senior Clinical Data Manager

<h1><u>Non-Solicitation Policy and Notice to Agencies and Recruiters:</u></h1><p><b>IDEAYA&#39;s Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships</b>.  Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation.  Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences.  All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function.  All communication by external agencies and recruiters must be directed to humanresources&#64;ideayabio.com.  We ask that you only email your interest once.</p><p></p><p style="text-align:left"><u>Job Summary</u></p>About IDEAYA Biosciences:<br><br>IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. <br><br>When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.<br><br>Location: South San Francisco, CA.<br><br>Position Summary:<br><br>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.<br><br>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.<br><br>This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.<br><br>Reporting to: Senior Director, Data Management<p></p><p></p><p style="text-align:left"><u>Job Description</u></p><p><b><span>What you’ll do:</span></b></p><ul><li>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</li><li>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</li><li>Represent data management in Study Management Team (SMT) meetings; proactively identify and communicate risks, suggest solutions and provide updates</li><li>Establish and maintain strong relationships with cross-functional teams, vendors and key stakeholders for successful execution of clinical trial</li><li>Collaborate with study statistician and statistical programmer to support production of clinical trial reports and other study deliverables</li><li>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)</li><li>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</li><li>Maintain study DM related documents for inspection readiness</li><li>Develop data transfer agreements with external vendors</li><li>Review and provide feedback on clinical documents (e.g., clinical protocols, statistical analysis plans, protocol deviation plans, vendor specifications)</li><li>Report data management metrics and trends; proactively identify barriers to timely and successful trial execution and propose solutions</li><li>Lead clinical data review of data listings, external data reconciliation reports, SAE reconciliation and implement data review strategy</li><li>Serve as a subject matter expert on data management systems and processes</li><li>Contributes to the development and improvement of data management standard operating procedures (SOPs) and document templates</li></ul><p></p><p><b><span>Requirements:</span></b></p><ul><li>Bachelors in life sciences or related discipline with at least 8 years of experience in clinical data management</li><li>Requires extensive knowledge of clinical data management principles, clinical trials process and regulatory requirements</li><li>Strong experience with late phase oncology trials is preferred</li><li>Strong verbal and written communication and critical thinking skills</li><li>Experience in Veeva CDMS system is a plus</li><li>Experience with MedDRA and WhoDrug medical coding</li><li>Excellent ability to manage competing priorities in a changing environment</li><li>Strong working knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelines</li><li>Proficient on EDC configuration and design, testing and validation, data collection and data review process, and data standardization</li><li>Self-motivated and takes pride in your work</li><li>Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships</li><li>Attention to detail, ability to proactively identify issues and address with solutions-oriented approach</li></ul><p></p><p><span>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.</span></p><p></p><p><span>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</span></p><p></p><p></p><p><b><span>Total Rewards</span></b></p><p><span>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. </span></p><p></p><p><span>The expected salary range for the role of Senior Clinical Data Manager is $</span> <span>$179,000 - $221,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process. </span></p><p></p><p><span>The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite in the office at the Company’s facilities for training &amp; meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, 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.</span></p><p></p><p><span>IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.</span></p><p></p><p><span>We are committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please get in touch with us at hr&#64;ideayabio.com.</span></p><p></p>