BBOT ยท 2 hours ago
Director/Senior Director, Clinical Data Management
United States
Full-time
Remote
Director/Executive
$220K/yr - $286K/yr
12+ years expBBOT is a clinical-stage biopharmaceutical company focused on advancing novel small molecule therapeutics for cancer treatment. The Director/Senior Director of Clinical Data Management will lead clinical data management activities, ensuring data integrity and adherence to industry guidelines across multiple studies.
Biotechnology
Responsibilities
Provide data management input for clinical study teams and the Development department. Represent and communicate data management activities, progress, and risks to cross- functional leads
Lead and manage clinical data management tasks and activities for assigned clinical trial(s) from study start up to study closeout
Manage and provide oversight of vendors (including clinical data management CRO) to ensure the data are complete, accurate and delivered within the agreed upon timelines, including timely filing of all DM related plans and documents to eTMF
Oversee Data Management functional budget and perform budget review for outsourced data management activities
Ensure inspection readiness by maintaining current documentation, adherence to industry guidelines, SOPs and compliance with training
Work collaboratively with internal and external team members within the study to coordinate the planning and execution of clinical data management activities and data deliverable timelines in support of overall clinical development strategies
Create strategies for rapid study start and database lock to increase clinical data management productivity
Oversee CRO EDC database build and lead the design of eCRFs and ensure that they align with the clinical protocol(s)
Ensure complete and accurate documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plans
Ensure data is reviewed on an on-going basis, including individual subject data within the EDC, datasets, TLFs, etc. that are generated for Regulatory Agency interactions, CSRs, DSURs, IBs, and other business needs; collaborate with programming to identify data cleaning gaps to create additional line listing outputs and facilitate internal medical line listing review / issuing and resolving queries
Collaborate with clinical development team and provide expertise regarding CDISC data standards, FDA and ICH guidelines, and GCDMP standards
Help establishing CDM processes and contribute to the development of key clinical data management SOPs
Provide technical support and guidance for clinical data management team and vendors around project conventions, standards, practices, and database specifications
Qualification
Required
Bachelor's degree in a scientific discipline or equivalent (computer science, mathematics, statistics, epidemiology, biology, psychology)
Minimum of 12 years of clinical data management experience within pharmaceutical industry with a track record of success and progression for Director level
Minimum of 15 years of clinical data management experience within pharmaceutical industry with a track record of success and progression for Senior Director level, including prior experience managing a team
Direct experience working with Medidata Rave design and implementation; direct experience with IXRS development and implementation
Must have strong knowledge of ICH and GCP and Data Management processes and systems and be proficient in regulatory requirements for clinical data management and the regulatory submission process
Extensive experience working with external vendors, including but not limited to acquisition, contracting, evaluation of vendor's capabilities and ensuring the desired high-quality deliverables
Demonstrated ability to operate and lead assigned study in a dynamic organization, build successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise
Able to adapt quickly to the changing needs of the organization
Able to organize multiple work assignments and establish priorities
Excellent verbal and written communications skills; able to communicate proactively and effectively
Benefits
Annual bonus
Stock-based long-term incentives
Medical, dental, and vision benefits
Retirement
Wellness stipend
Flexible time off
Company
BBOT
BBOT (BridgeBio Oncology Therapeutics) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase