ASSOCIATE DIRECTOR, DATA MANAGEMENT

2 weeks ago

CA United States Alumis Inc Full time
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.

The Associate Director, Data Management (AD, DM) will be responsible for ensuring high-quality management of clinical trial data in a rapidly evolving environment, in accordance with industry standards. The AD, DM will be responsible for executing DM activities and deliverables across multiple studies, leading key data management activities including Case Report Form (CRF) design, clinical database development, creation of Data Management Plans, external data transfer agreements, and CRF completion guidelines, implementation of programmed edit checks and data quality listings, clean patient tracking, and database closure. This position will report to the Senior Director, DM or higher.

Responsibilities include and are not limited to

  • DM Study Lead one or more studies
  • Represent CDM in cross-functional meetings
  • Ensure DM project deliverables are completed on time and in accordance with quality standards and regulatory requirements from study start-up through study closure/archival
  • Apply effective vendor management throughout the study
  • Responsible for ensuring complete and accurate CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans
  • Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts and executing testing as applicable
  • Ensure accurate development and execution of data integrations between EDC, IXRS and/or external vendor data sources
  • Responsible for setup and management of data transfers for assigned studies, including review of test data transfers for consistency with data transfer agreements
  • Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells
  • Perform supplemental data reviews according to the data quality checks outlined in the data validation specifications or Clinical Data Review Plan (CDRP)
  • Participate in reviews of blinded TFL output prior to final database locks
  • Report query trends and data/query/SDV metrics to the Study Execution Team (SET)
  • Participate in the development of EDC custom report specifications, SAS Clinical Programming report specifications and/or associated outputs as needed
  • Ensure DM project documentation is in an inspection-ready state
  • May lead initiatives focused on DM process improvement, data quality assurance and efficiency

Qualifications

  • 10+ years of relevant experience and has earned a BS or equivalent degree; MS or MBA a plus
  • Experience running Ph I-IV clinical trials, both in-house and through CRO partners
  • Strong knowledge and experience in EDC and other key technologies (e.g., IXRS, data visualization)
  • Proficiency in CDISC standards (CDASH, SDTM, ADaM)
  • Experience with SAS, SQL and/or other clinical programming tools
  • Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP
  • Depth of experience across all aspects of DM, including but not limited to: CRF and database development, data quality assurance and analytics, data transfer management, vendor management, DM study documentation and inspection readiness.
  • Strong understanding of the application of MedDRA and WHO Drug clinical data coding classification systems
  • Strong interpersonal, organizational, and communication (oral and written) skills
  • Demonstrated ability to cultivate strong working relationships with internal and external colleagues.
  • Logical thinking, attention to detail and accuracy, strong organizational skills, and problem-solving abilities
  • Ability to prioritize and to adapt quickly to changing business conditions with a can-do attitude
  • Capable of proactively identifying project challenges and risks and proposing appropriate and strategic solutions to issues.

Alumis Values
• We Elevate
• We Challenge
• We Nurture

This position is located in South San Francisco, CA. At this time, we are not considering fully remote applicants.

The salary range for this position is $ 190,000 USD to $225,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices.

Alumis Inc. is an equal opportunity employer.

  • Director, Data Strategy

    4 days ago

    Frisco, TX, United States Comerica Full time

    Director, Data Strategy & GovernanceThe Director, Data Strategy & Governance will have responsibility for developing and delivering the enterprise data strategy. In this capacity, they will be the functional lead for the enterprise data strategy, collaborating with business stakeholders and the data practitioner community to define business needs and...

  • Director, Data Strategy

    4 days ago

    Frisco, TX, United States Comerica Bank Full time

    Director, Data Strategy & GovernanceThe Director, Data Strategy & Governance will have responsibility for developing and delivering the enterprise data strategy. In this capacity, they will be the functional lead for the enterprise data strategy, collaborating with business stakeholders and the data practitioner community to define business needs and...

  • Data Solutions Lead, Managing Director

    7 days ago

    Boston, MA, United States State Street Corporation Full time

    Who we are looking for The Managing Director, Finance and Treasury Data Solutions, will lead a transformative effort to define, change, and implement data-centric solutions for finance, treasury and business units (GD and Product), aiming to drive operational efficiencies through improved data design and management. The Managing Director will drive our...

  • Manager, Data and Analytics

    2 weeks ago

    United, United States Just Born Full time

    Manager, Data and Analytics The Manager, Data and Analytics role isresponsible for planning, designing, implementing and launching efficient andsecure data processes and policies for the Company. The successful candidate will work acrossbusiness units and build a strategic plan for utilizing, validating andsecuring data across multiple systems. This is a...

  • Director of Nursing

    3 days ago

    Kalamazoo, MI, United States Food Management Search Full time

    DIRECTOR OF NURSING - Location: Kalamazoo, Michigan. Direct Hire Competitive Compensation based on experience. Full-time Benefits Package Relocation Assistance Available - Possible. Bonus Eligible - Yes We are currently searching for a Director of Nursing for a 97-bed skilled and rehabilitation center that is rated 5-stars in...

  • Director of Data Governance

    6 days ago

    New York, NY, United States Focus Capital Markets Full time

    We are looking for a leader with past experience in building and implementing a data governance program in a technically innovative firm to optimize the value of our data assets and digital products that provide revenue-generating insights. In this role, you will oversee the strategy of data governance from its conception to implementation, creating unified...

  • Associate Director for Women and Infants

    4 weeks ago

    Philadelphia, PA, United States Temple University Hospital Full time

    Associate Director for Women and InfantsAssociate Director for Women and Infants 40hrs Evening 3-11 -Temple Hospital Under the direction of the Director, Nursing, the Associate Director provides oversight of the nursing care provided to patients on a nursing unit. Maintains standards of service excellence and nursing practice. Develops evidenced based...

  • Director R&D Data Engineering, Data Analytics

    7 days ago

    Alameda, CA, United States Abbott Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.The...

  • QUALITY MANAGEMENT NURSE ASSOCIATE LPN

    3 weeks ago

    , NY, United States CVS Pharmacy, Inc. Full time

    Quality Management: OD Correspondence team. This fast paced team is responsible for reviewing and approving all pre-service post-acute denial correspondence. You'll be collaborating with RNs and Medical Directors on appropriate denial letter language Management, Associate, Nurse, Medical Director, Quality, Retail, Healthcare

  • Associate Director, Due Diligence

    7 days ago

    Washington, DC, United States TD International Full time

    TDI — strategic advisory and risk intelligence firm—is currently seeking an Associate Director to join our Due Diligence and Investigations (DD&I) practice in our Washington, D.C. office.  The DD&I practice is responsible for conducting sophisticated open-source and human intelligence investigations that directly inform our client’s most critical...

  • Director, Data Integrations Product Manager

    7 days ago

    Pennington, NJ, United States BNY Mellon Full time

    Overview Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the "bank of banks" - 97% of the world's top...

  • Associate Director ABS Quant

    3 days ago

    New York, NY, United States Selby Jennings Full time

    Title: Associate Director ABS Quant Salary: $225,000 + Total Compensation A top tier global investment bank is currently building out their ABS trading desk and looking to make the very first quant hire to support the desk. The ideal candidate will join as an Associate Director and have a deep product knowledge of ABS & MBS modeling skills. This is an...

  • Human Resources Senior Director Hospital

    6 days ago

    Carlsbad, CA, United States Clinical Management Consultants Full time

    A large hospital in southern California is excited to hire their next Human Resources Director.The Human Resources Director will work with the hospital CEO and be part of the senior leadership team. The Human Resources Director oversees a team of healthcare professionals and experienced human resources professionals. The human resources department at this...

  • Clinical Research Associate

    7 days ago

    , CA, United States TalentBurst, Inc. Full time

    Industry: Medical DevicesPosition: Clinical Research Associate with Ophthalmology ExperienceLocation: Remote (However, candidates will need to be in specific states as they may occasionally have to go into the officeDuration: 24 Months ContractNote : 3 days a week at the site. (Travel expense will be reimbursed)Preferred locations: CA- Northern California-...

  • TRANSITION ASSOCIATE

    2 weeks ago

    , CA, United States AchieveKids Full time

    Transition AssociateReports To: Director of EducationPosition Status: Non-ExemptJOB SUMMARYThe Transition Associate/Vocational Counselor is responsible for providing classroom coverage as needed, and for supporting students in identifying vocational opportunities and assisting the student in their successful performance of the vocational opportunity.The...

  • Clinical Data Manager

    2 weeks ago

    Redwood City, CA, United States Revolution Medicines Full time

    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...

  • Physician- Associate Program Director Internal Medicine

    4 weeks ago

    Riverdale, GA, United States Southern Regional Medical Center Full time

    With oversight and direction from the Program Director(s), the Assistant Program Director is responsible for the operational functions of the accredited GME training programs. The position requires a comprehensive and detailed understanding of the national accreditation policies and hospital policies, as well as a high degree of initiative and independent...

  • RN DIRECTOR SURGICAL OPERATIONS

    2 weeks ago

    Cocoa, FL, United States Clinical Management Consultants Full time

    Are you ready to lead the surgical services team of a prestigious hospital while living a charming coastal lifestyle? A renowned 150 bed hospital on the beautiful Canaveral Coast of Florida is seeking a dynamic and experienced RN Director Surgical Op Director, Operations, Surgical, RN, Nurse Manager, Operation, Healthcare, Staffing

  • Senior Data Management Lead

    3 days ago

    Sacramento, CA, United States eStaffLLC Full time

    Our Sacramento based client is seeking a highly skilled Senior Data Management Practice Lead to join their consulting leadership team working on-site with the team or clients 3 days/wk. In this director-level role, you will be hands-on, leading their data management practice, overseeing projects and teams of data professionals, and serving as the primary...

  • Night RN Telemetry Assistant Director

    11 hours ago

    Beachwood, NJ, United States Clinical Management Consultants Full time

    A prestigious 500 bed hospital nestled in a charming coastal community near central-eastern New Jersey, as a Night RN Telemetry Assistant Director! The Night RN Telemetry Assistant Director will have extensive opportunities for learning and career ad RN, Director, Telemetry, Assistant, Night, Nurse Manager, Healthcare, Staffing