Director, Clinical Data Management

Director, Clinical Data ManagementThe Director, Clinical Data Management, is accountable for timely and high-quality data management deliverables supporting the BlossomHill Therapeutics portfolio. The incumbent will be accountable for conducting oversight of Data Management activities at the program or study level - as performed by CROs or other 3rd Party Vendors - to ensure they meet obligations as described in ICH-GCP and BlossomHill Therapeutics Scope of Work, maximize effectiveness and maintain budgets.The Director, Clinical Data Management, provides the best industry practices and changes in data management processes, DM vendor management expertise in support of development programs as well as post-marketing registration and non-registration studies.Key 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.Qualifications: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.Line management experience or equivalent (prior second-level management experience preferred).Proven track record of strong project management skills and experience managing data management activities.Experience with all phases of development in one or more oncology programs preferred.Ability to handle multiple development programs simultaneously.NDA/CTD Experience preferred.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.AAP/EEO Statement:The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.Recruiters and Agencies:BlossomHill Therapeutics does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to BlossomHills’ employees is strictly prohibited. Unsolicited referrals and resumes sent to BlossomHill Therapeutics are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired.

Salary : $219,000 - $248,500