Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons – firstname.lastname@example.org
Associate Director, Data Manager will report to the Head of Biometrics. The successful candidate would serve both in a leadership capacity, and in providing hands-on support to the team. This individual brings advanced understanding of the clinical data management process from study start-up through database lock, including database design and data validation as per the requirements in the clinical study protocols, data review plan, & data management plan, regulatory data standards and oversees the compliance activities across multiple CROs as it relates to data management. The scope of this role may span multiple programs and across multiple CROs Duties and Responsibilities:
- Responsible for vendor oversight activities across global development programs, including cross-vendor oversight of data transfers, data integrations, and data output to support study requirements.
- Represents data management function on Clinical study and program teams, ensuring aligned expectations between the CRO and client for all data related deliverables, especially in support of key decision points and regulatory submissions.
- Contributes influential leadership in collaboration with other Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
- Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.
- Ensures archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
- Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Regulatory, Safety, Clinical Operations, Statistical Programming and Statistics.
- Designs and maintains SOPs, process maps, templates and timelines to support function’s operational and oversight models.
- Contributes or Leads functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, or functional requirements.
- Ensures compliance with own Learning Curricula, corporate and/or GXP requirements.
- MS or BS in health-related, life sciences area or technology-related field.
- Minimum of 8 years data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
- Proven track record of strong project management skills and experience managing data management activities for rare disease development programs.
- Experience with all phases of development in one or more therapeutic areas preferred.
- Ability to handle multiple development programs simultaneously.
- NDA/CTD Experience preferred.
- Strong knowledge of data management best practices & technologies as applied to clinical trials.
- Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
- Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
- Advanced knowledge of broad drug development process with expertise in the cross functional interfaces with the data management function.
- Strong knowledge of relational databases and experience using multiple clinical data management systems.
- Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
- Ensures adherence to functional budget, and provides timely updates to manager regarding additional, potential spend or cost savings.
- Expert knowledge of CDISC standards, SDTM preferred. Good experience leading standards selection and implementing in clinical trials is ideal.
- Expert knowledge of general of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.