Director, Clinical Data Management Operations - Job ID: 1135
As leader in the CDM group and subject matter expert for CDM, the individual in this position will oversee data management activities associated with clinical drug development for all clinical trials therapeutic areas (e.g., Endocrinology, Oncology, etc.). The duties of this role include CDM oversight including strategic resourcing, timeline planning, process improvement, data standards development and implementation, and participation in cross-functional initiatives. The responsibilities of this position also include partnering and collaborating with other functional groups and external vendors to ensure timelines and quality of project deliverables, creating, updating, and maintaining SOPs to ensure the validity of clinical trial databases, and being familiar with the implementation of Good Clinical Practice (GCP) as it applies to CDM. The individual will also provide leadership to the CDM group by leading organizational change; developing and empowering staff; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
- Serve as the inter-department subject matter expert for CDM within the assigned therapeutic areas and trials to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making, regulatory approval and market acceptance
- Serve as a key contributor to evaluate, implement, and lead process and infrastructure development/improvement as well as staffing within the assigned TA and trials to build the CDM function to support the growing clinical pipeline. This may include external vendor management and development, systems evaluation and selection, external data integration, ad-hoc analysis, and end-to-end data standards
- Ensure compliance regarding protocols, SOPs and overall clinical objectives within the assigned TA and trials. Help ensure the continued development, review and updating of SOPs and process documentation in accordance with corporate, industry and regulatory agency standards
- Assist with implementing the corporate strategic plan within the department – planning and managing internal and external CDM resources, and managing the department budget
- Provide strategic, organizational, and operational management and guidance to the personnel and teams within the assigned TA and trials
- Provide technical and functional oversight of the day-to-day work and work products of clinical data management staff within the assigned TA and trials, as needed, including clinical data collection, processing, and quality control procedures, timelines, and documentation
- Assist with the selection and management of data management vendors; identify potential risks and resolving issues with CROs; oversee vendor management plans and reviewing quality metrics; provides guidance and monitors the progress of DM activities with CROs or other vendors
- Contribute to identifying, locating, evaluating, and validating CDM documents and databases required for report generation or regulatory submission
- May assist with the coordination of non-routine projects as applicable in support of Development Operations initiatives
- Collaborate with cross functional peers to facilitate and optimize the product development and registration process
- Bachelor’s degree in life sciences (e.g., biology), computer science, statistics, etc. or equivalent combination of a bachelor’s degree and relevant job experience. Graduate degree is preferred but not required.
- At least 15 years of relevant data management experience and at least 6 years of managerial experience leading CDM teams in the biotech, pharmaceutical, medical device or CRO industry, including experience in multiple therapeutic areas and in various phases of drug development.
- Prior experience leading CDM infrastructure setup & deployment and CDM process improvement.
- Prior experience with CRO selection and oversight as well as management experience in clinical trial data collection systems (EDC, eCOA, CTMS, Drug Safety Database Systems, IVRS/IXRS, reporting tools, data visualization, etc.) and practical knowledge of data integration between data collection systems.
- Detailed knowledge of data standards (CDISC, CDASH, SDTM) in the clinical environment.
- In depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry. Competence in SAS programming is a plus.
- Demonstrated leadership quality and superior organizational and interpersonal skills. Excellent written and verbal communication skills.
- Knowledge of the current industry best practices, FDA and ICH regulations, ICH-GCP, GCDMP and other applicable local and international regulations.
- New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
- Salary Range: $225-245K/year
- Medical insurance
- Vision insurance
- Dental insurance
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance
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