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Senior / Principal Clinical Data Manager
South San Francisco, California, United States
Who We Are
23andMe, the leading consumer genetics and research company, has accumulated a wealth of genotypic and phenotypic information from participants committed to improving human health through advances in genomics. Our Therapeutics team in South San Francisco leverages this data to discover and develop new treatments that can offer significant benefits for patients with serious, unmet medical needs.
This dedicated research and drug development group identifies novel targets using 23andMe's genetic database and performs preclinical research to advance programs towards clinical development. We currently have programs across several therapeutic areas, including but not limited to oncology, respiratory, and cardiovascular diseases. More information about our Therapeutics team is available at https://therapeutics.23andme.com/.
We are seeking an outstanding Senior / Principal Clinical Data Manager to join a collaborative, cross-functional Development organization focused on bringing genetically-validated therapies to patients with high unmet need. Successful candidates will have experience independently supporting end-to-end data management activities for multiple clinical development programs.
More information about our Therapeutics team is available at https://therapeutics.23andme.com/
What you'll do
- Represent the clinical data management function on therapeutics development project teams at 23andMe
- Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status.
- Provide expertise and guidance to the Development function and study management teams regarding data standards
- Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines
- Develop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock.
- Manage data transfers with CROs and third-party data sources, adverse event reconciliation and MedDRA / WHO-DD coding.
- Support the locking, and archiving of study databases.
- Prepare, consult on and implement recommendations for new or improved processes for data management and data flow.
- Effectively interact with colleagues in the biometrics function for strategic planning to ensure internal standards in accordance with corporate objectives
- Build and lead a team of high performing clinical data management consultants / vendors to meet business goals
- Effectively represents CDM's work to senior management and key external influencers, forums or bodies
- Operate with considerable independence and autonomy on most assignments, often using ingenuity to determine the best way to approach and deliver against objectives and goals.
- Effective education of cross-functional partners on clinical data management practices and processes to strengthen cross-functional project results and team capabilities.
What you’ll bring
- BS, MS or PhD in statistics, computer science or other field relevant to biometrics programming
- Extensive industry experience in clinical data management or related biometric and programming functions. Routinely acted as a functional lead on multiple projects that extend across multiple products and regulatory phases.
- Able to independently develop, lead and manage clinical data management plans, including study timelines, for one or more products or indications. Proven effectiveness supporting study start-up, maintenance, database lock and clinical study report submissions.
- Experience acting as a clinical data management lead to regulators, on cross-functional disease or therapeutic area planning, study audits and inspections.
- Extensive industry knowledge, including in-depth understanding of multiple drug development phases and varying regulatory requirements across different phases. In-depth understanding of cross-functional team roles and responsibilities involved in drug development.
- Strong knowledge of one or more of our therapeutic and disease areas, core clinical data management processes, standards, tools and technologies. In-depth knowledge of FDA, ICH, GxP and other relevant standards, guidelines and requirements. Demonstrated comprehension of product and safety profiles. Proven effectiveness managing study analysis and reporting and contributing to regulatory submissions.
- Ability to create robust SOPs or other procedures, processes and tools used by many.
- Experience overseeing and guiding the work of less experienced team members, consultants and/or CROs.
- Ability to think strategically; consistently works to improve clinical data management or team outcomes and ways of working
- Advanced communication skills to convey complex information to both specialist and non-specialist audiences. Consistent communication in a manner that builds trust and enhances alignment with others.
- Routinely goes out of her/his way to help others. Takes initiative to support the whole team. Appreciates and leverages diversity across the team. Highly regarded as a trusted advisor to cross-functional partners and stakeholders.
- Proactive and highly self-motivated with strong analytical and troubleshooting skills.
Note: Job title will be commensurate with experience and academic credentials.
23andMe, Inc. is the leading consumer genetics and research company. Founded in 2006, the mission of the company is to help people access, understand, and benefit from the human genome. The company was named by Glassdoor as one of the Best Places to Work in 2019, MIT Technology Review to its “50 Smartest Companies, 2017” list, and named one of Fast Company’s “25 Brands That Matter Now, 2017”. 23andMe has millions of customers worldwide, with more than 80 percent of customers consented to participate in research. More information is available at www.23andMe.com.
At 23andMe, we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at email@example.com. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.
Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.Back