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BlossomHill Therapeutics, Inc. · 1 day ago

Director, Clinical Data Management

San Diego, CA

Full-time

Onsite

Director/Executive

$219K/yr - $248K/yr

10+ years exp

BlossomHill Therapeutics, Inc. is dedicated to delivering high-quality data management for their portfolio. The Director, Clinical Data Management, is responsible for overseeing all data management activities, ensuring compliance with industry standards, and managing vendor relationships to support clinical studies.

BiopharmaBiotechnologyHealth CareOncologyPharmaceuticalTherapeutics

Responsibilities

Accountable for all vendor oversight activities across all assigned development programs within BlossomHill Therapeutics. Represent data management function on the Clinical Study team ensuring aligned expectations between the CRO and BlossomHill for all data related deliverables, especially in support of key decision points and regulatory submissions

Partner with appropriate stakeholders to resolve issues escalated from the vendor and/or cross-functional teams

Participate in preparing function for submission readiness and may represent function in a formal inspection or audit

Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents

Accountable for the achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Pharmacovigilance & Safety, Regulatory Affairs, Biostatistics, Statistical Programming, Clinical Pharmacology Clinical Science and Clinical Development. This includes accountability for coordinating functional resources to support all studies within scope to ensure delivery of the design and implementation of data capture tools, data processing, coding and validation

Act as a Data Management process expert for operational and oversight activities

Maintain SOPs, process maps and templates and timelines to support functions operational and oversight needs

May prepare metrics to support the function’s KPIs

Represent function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc., to identify industry best practices and increase the visibility of BlossomHill Therapeutics

Work cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables

Identify and recommend changes in industry best practices and/or regulatory trends

Ensure compliance with own learning curricula, corporate and/or GXP requirements

Qualification

Data ManagementVendor ManagementClinical Trial KnowledgeProject ManagementDrug Development ProcessRegulatory KnowledgeLine ManagementOncology ExperienceNDA/CTD ExperienceBiometrics Knowledge

Required

BS/BA required, preferably in a health-related, life science area or technology-related field

10+ years of data management and/or drug development process with expertise in the cross-functional interfaces with the data management function

4+ years experience managing vendor relationships and alliance partnerships

Proven track record of strong project management skills and experience managing data management activities

Ability to handle multiple development programs simultaneously

Expert knowledge of Clinical Trial, Biometrics (Statistics, Clinical Data Management, Statistical Programming), IT and/or System Maintenance best practices, standards library development and maintenance

Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes

Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the Clinical Development functions

Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process