Clinical Data Management
Position Summary
For our fast-growing team, we are looking for a Director Clinical Data Management (100% with location US) reporting to the SVP, Head Global Clinical & Regulatory Operations. In this role you provide strategic planning, execution, and oversight of clinical trial data deliverables. You are responsible for on-time, quality data management deliverables supporting the Noema portfolio. In addition to that, you are also responsible for driving development and execution of Noema CDM standards, conducting oversight of data management activities at the program, group of programs and/or portfolio level, as performed by CROs, to ensure vendors meet obligations as described in ICH-GCP and Noema’s Scope of Work, maximize effectiveness and maintain budgets
Responsibilities
- Leads data management activities for outsourced studies and manages vendors responsible for performing those activities from start-up through database lock.
- Establish Program(s) or Portfolio level strategies and services; accountable for the management of vendor partnerships to maximize effectiveness and maintain budgets.
- Provides data management expertise and capability in support of global development programs; identifies and executes industry best practices.
- Leads the creation, maintenance and execution of Noema study data review plans developing and executing Noema’s internal data review, including resulting query management and resolution.
- Represents data management function on the study team(s) ensuring aligned expectations between the CRO and Noema for all data related deliverables, especially in support of key decision points and regulatory submissions.
- Oversees data management vendor deliverables according to timelines including but not limited to edit checks (data validation plan), data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, and database lock plans.
- Performs management & oversight of all study-level data capture (e.g., EDC, IRT, ePRO, eCOA) technologies and other related vendors and/or applications.
- Partners with appropriate stakeholders from the vendor and/or cross-functional teams to ensure data quality and on time delivery; seeks creative solutions and resolves issues.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents; participates in preparing function for submission readiness.
- Responsible for the achievement of major data management deliverables and milestones in coordination with other functions.
- Develops SOPs, process maps and templates and timelines to support functions operational and oversight models.
- May prepare metrics to support the function’s KPIs.
- Performs other duties as assigned.
- Domestic/international travel (5-15%) may be required.
Qualifications
- Bachelor’s Degree or international equivalent preferred.
- 7+ years data management and drug development process with expertise in the data management function including project management and management of data across drug development programs.
- Experience with all phases of development in one or more therapeutic areas preferred.
- Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
- Experience implementing data management best practices, industry data management standards and developing an organization’s data management function.
- Demonstrated expertise providing input into clinical trial documents (protocols, statistical analysis plans, CRFs, study reports).
- At least 2 years’ experience managing vendor relationships and alliances.
- Minimum 2 years of line management experience or equivalent.
- NDA/CTD Experience preferred.
- Ability to travel domestically and internationally.
- Fluent in English; facility with multiple languages a plus
Apply
If you are interested in this position please email our HR department with your resume and cover letter at: career@noemapharma.com