Director/Sr. Director, Clinical Data Management
At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
In this role, you will provide end-to-end oversight across all clinical data management activities, including clinical trial data management, establishment /management of clinical trial data standards, eCRF development, clinical trial data reconciliation, medical coding, etc. You will be responsible for ensuring functional input towards vendor selection and day-today functional oversight of outsourced data management activities. In addition, you will collaborate with the Clinical Informatics & Analytics team to ensure validation of clinical data systems and data repositories and seamless external data transfers/integration. The Director/Senior Director, Clinical Data Management role requires a thorough understanding of clinical data, and its collection, to ensure quality and regulatory compliance, oversight of its management/acquisition and assurance of its integrity in the clinical trial process.
You will help grow the Clinical Data Management function and provide leadership/coaching of the Clinical Data Management group. You will ensure implementation and accountability of the data strategy at trial and program-level by ensuring that Data Management processes, standards, templates, and best practices are fit-for-purpose to meet trial/program needs.
Key Responsibilities:Drives overall clinical trial data management and standards to ensure data is handled consistently from start-up through database lock, ensuring development of processes and standards, e.g., standard data collection, data transfer specifications, eCRF instructions, Data Management Plan, and other clinical data review standards.Within study teams, gives input to protocol design, database design, and validation, and data management plans, including data review strategies and data quality assurance, plans to ensure alignment with planned analysis and reporting objectives.Leads eCRF standardization to ensure protocols are conducted in alignment with portfolio-level standards, SOPs, and regulatory requirements.Partners within DICE to ensure record retention plans for clinical data management are in accordance with DICE SOPs and ICG-GCP ensuring adequate level of documentation, e.g., data repositories, etc.At the study-level, proactively drives quality, efficiency, and innovation to ensure clinical data management deliverables are met within the established timelines, budget, and quality/compliance standards.Ensures effective vendor oversight and management of vendors/external partners performing clinical data management services on behalf of DICE by defining functional scope /cost of projects, and providing ongoing monitoring of key performance indicators, metrics and quality of clinical data management deliverables.Provides functional oversight of systems within Clinical Data Management in relation to implementation, validation, audit trail, access controls, system oversight, etc.Drives the development of clinical data management outsourcing strategies and creates positive relationships with internal stakeholders, e.g., Contract Management, Vendor Management, etc.Oversees development of standards tools related to data cleaning activities, data listings, data report generation e.g., error detection, missing data, etc. to ensure standard processes and reports are generated across trials.Leads and actively contributes to the development, review, implementation, and improvements of departmental processes, policies, standard operating procedures, training, and work guidance as applicable.Effectively interacts with other functional areas to support the overall operational and strategic activities within Clinical Operations.Supports study teams during submission, inspection and/or other regulatory-related activities.Identifies and troubleshoots operational problems, issues, and obstacles, and helps study teams remove barriers.
Preferred Experience and Education:10+ years of experience in clinical data management in the pharmaceutical industry4 + years of experience with managing peopleStrong technical skills across multiple data platforms, including electronic data capture systems and data review applicationsStrong CDISC/SDTM skillsEarly and late study drug development experienceVendor management and oversight experience. Adept at ensuring services provided by clinical data management vendors and contractors are performed within established timelines and quality/compliance standardsExtensive experience with implementing effective portfolio-level clinical data management practices, especially within the oncology therapeutic areaExtensive experience with process development within data managementStrong analytical skills and demonstrated experience n gathering, interpreting, and analyzing data in clinical research and drug developmentExperience with regulatory GCP inspections/audits, a plusThorough command of FDA/EMA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
Preferred Additional Skills:Excellent interpersonal and communication skills, both verbal and writtenConsummate team player with excellent collaboration skillsCapable, creative problem-solverAbility to communicate technical information to non-scientists, and willingness to educate internal teamStrong customer-orientated awareness and focus; strives to support others to succeedPronounced quality focusProactive and open-mindedStrong leadership skills with the ability to influence decisions and achieve resultsAbility to adjust to multiple demands, shifting priorities, and unexpected events while maintaining a positive work attitudeResult and goal-oriented and committed to contributing to the overall success of DICE
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.