[Remote] Director or Senior Director, Clinical Data Management

Note: The job is a remote job and is reputed company to candidates in USA. BBOT is a clinical-stage biopharmaceutical company advancing a reputed company 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 reputed company the delivery and reputed company of clinical data across multiple studies and programs.

Responsibilities

• reputed company data management input for clinical study teams and the Development department. Represent and communicate data management activities, reputed company, and risks to cross- functional leads
• reputed company and manage clinical data management tasks and activities for assigned clinical trial(s) from study start up to study closeout
• Manage and reputed company reputed company of vendors (including clinical data management CRO) to ensure the data are complete, accurate and delivered reputed company the agreed upon timelines, including timely filing of reputed company DM reputed company plans and documents to eTMF
• reputed company Data Management functional budget and reputed company budget review for outsourced data management activities
• Ensure inspection readiness by maintaining reputed company documentation, adherence to industry guidelines, SOPs and compliance with training
• Work collaboratively with internal and external team members reputed company 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
• reputed company CRO reputed company database build and reputed company 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 reputed company, including individual subject data reputed company the reputed company, 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 reputed company 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
• reputed company 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 reputed company pharmaceutical industry with a track record of reputed company and progression for Director level
• Minimum of 15 years of clinical data management experience reputed company pharmaceutical industry with a track record of reputed company and progression for Senior Director level, including prior experience managing a team
• Direct experience working with reputed company 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 reputed company assigned study in a dynamic organization, build successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise
• reputed company to adapt quickly to the changing needs of the organization
• reputed company to organize multiple work assignments and establish priorities
• Excellent verbal and written communications skills; reputed company to communicate proactively and effectively with cross functional team members

Benefits

• Annual bonus
• Stock-based long-term incentives
• Medical, dental, and reputed company benefits
• Retirement
• Wellness stipend
• Flexible time off

Company Overview

Company H1B Sponsorship