Note: The job is a remote job and is open to candidates in USA. BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. They are seeking a highly motivated Director or Senior Director of Clinical Data Management to lead the delivery and integrity of clinical data across multiple studies and programs.
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
Skills
- 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 while anticipating growth in the product pipeline
- 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 with cross functional team members
Benefits
- Annual bonus
- Stock-based long-term incentives
- Medical, dental, and vision benefits
- Retirement
- Wellness stipend
- Flexible time off
Company Overview
Company H1B Sponsorship