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USA - Clinical Data Management & Technology (CDMT) Contractor V
Ref No.: 18-12187
Location: Cambridge, Massachusetts
Start Date / End Date: 10/15/2018 to 04/15/2019
Position Title: Senior Manager-Clinical Data Solutions

OBJECTIVES:
  • Responsible for timely and high quality data management deliverables supporting the Client portfolio.
  • Establish asset and study level strategies and services, including excellence in the application of standards.
  • Conduct oversight using, predictive data monitoring practices from database activation through database release and submission.
  • Contributes to the management of vendor partnerships to maximize effectiveness and maintain budgets.
  • Provides and enables solutions for complex problem solving that align with the Client values.
  • Serves as a clinical data management expert and provides guidance on CDISC standards.

ACCOUNTABILITIES:
  • Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team 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 Client Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
  • Provides input to functional governance with Client's strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
  • Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
  • Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents
  • Oversees the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
  • Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of Client.
  • Participates and represents function in formal inspections and audits as requested.
  • Other duties as assigned

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
  • BS/BA required preferably in a health-related, life science area and with a minimum of 10 years data management and/or drug development experience.
  • Proven track record of strong project management skills and experience managing data management activities for large drug development programs
  • Experience with all phases of development and at least 2 therapeutic areas.
  • Ability to handle multiple development programs simultaneously.
  • NDA/CTD Experience.
  • Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.
  • Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance.
  • Good understanding of CDISC standards, and experience implementing standards.
  • 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.
  • Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools.
  • Good working knowledge of general statistical programming processes and practices.
  • Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.

PHYSICAL DEMANDS:
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Ability to sit and stand for long periods of time.
  • Carrying, handling and reaching for objects.
  • Manual dexterity to operate office equipment i.e. computers, phones, etc.

TRAVEL REQUIREMENTS:
  • Access to transportation to attend various meetings held in proximity to the Client offices.
  • Able to fly to various meetings at investigator, vendor or regulatory agency sites.
  • Some international travel may be required.