Clinical Data Manager

Clinical Data Manager

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

JOB SUMMARY:

The purpose of this position is to provide therapeutic area/program data management expertise and leadership by:

• Defining the data capture and data management vendor strategies to meet the requirements of global development programs. Position may lead complex projects associated with various global alliances.
• Ensuring consistent program-level data collection, data cleaning and data management plan standards.
• Managing the collection, validation, coding and storage of clinical program data; enforcing standardization to maximize global data integration and inter-program efficiency.
• Directing the work of external vendors providing data capture technologies, data management programming capabilities and data processing capabilities to achieve quality, timely, cost-effective study deliverables.
• Coordinating program work of Data Manager and Senior Data Managers.
• Independently represent the global data management function in support of assigned clinical studies and programs lead from the US, EU or Asia. Independently represents the Data Management function in global, cross-functional teams and projects.
• Define complex study/program-level data capture and processing strategy including technologies and vendors to meet the needs of the project team and global development programs.
• Ensure consistent program-level data collection, data cleaning and data management plan standards.
• Enforces standards for the collection, validation, coding and storage of clinical program data to maximize global data integration.
• Directs the work of external vendors providing data capture technologies, data processing capabilities and data management programming capabilities to achieve quality, timely, cost-effective program/study deliverables.
• Define, manage and/or implement requirements and standards for (e)case report forms, EDC edit checks, clinical study database design, annotated CRF as well as data management plans including the data validation plan to meet the requirements of the clinical study.
• Ensure that the clinical study database and all data management deliverables are completed in accordance with the requirements of the data management plan and all applicable standards.
• Acts as ambassador for clinical data standards and standards governance process decisions
• Acts as a key resource at the study-team level on the rationale and principles in support of existing clinical data standards
• Archive all data management study documentation and original completed CRFs/DCFs and ancillary subject documentation.
• Manage performance of vendors, in addition to, Data Managers and Senior Data Managers, for studies/programs run from the US, EU or Asia through the following:
• Define program-level strategy for data management tasks and deliverables
• Provide Analytical Sciences functional requirements and review vendor
• Evaluate proposals and provide recommendation for vendor selection.
• Direct Analytical Sciences vendors in the coordination of meetings for Collaborate with vendors globally to define and manage standards for transfer performed by Analytical Sciences vendors for assigned clinical studies, including coordination with internal team members and external vendors management documents including bid grids, task orders and change orders.
• Analytical Sciences activities (e.g. Investigator Meetings, Project Kick-Off Meetings)of clinical study data between vendors and from vendors to.
• Apply new and existing data transfer standards to assigned studies. Provide technical direction for vendors supporting studies and programs he analysis needs of the statistician in the clinical study.
• Review and approve key data management vendor deliverables.
• Review study database design and derivations to ensure the database will meet
• Review study validations and/or edit checks to ensure the quality of the data
• Manage Analytical Sciences project plan, report on progress of Analytical Sciences deliverables, identify and resolve issues, coordinate activities with the project team and management for assigned compounds
• Anticipate and communicate resource and quality issues that may impact deliverables or timelines for a program or group of studies. Propose and implement solutions. Escalate issues to management as appropriate.
• Contribute to the assessment, definition and implementation of new processes, standards and technology.
• Comply with all applicable regulatory requirements and standards and procedures.
• Represents DM function on major matters regarding policies, plans and objectives and industry meetings as well as serve as a role model and mentor and thought leader for DM.
• Actively mentors Data Managers and Senior Data Managers.

Qualifications

EDUCATION, EXPERIENCE AND SKILLS:

• BS/BA required preferably in a health-related, life science area and with a minimum of 7 years data management and/or drug development experience.

• Experience with all phases of development and at least 2 therapeutic areas.

• Ability to handle multiple development programs simultaneously.

• NDA/CTD Experience.

• Previous experience with EDC study conduct.

• Advanced knowledge of relational databases (e.g., Oracle-based systems) and experience using multiple clinical data management systems including EDC.

• Strong knowledge of clinical study reporting requirements including SAS programming.

• Advanced knowledge of office software (Microsoft Office).

• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.

• Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles.

• Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.

LICENSES/ CERTIFICATION:

• Prefer Certified Clinical Data Manager (CCDM), as administered by the Society for Clinical Data Management (or equivalent certification).