Radius Health, Inc.

  • Associate Director, Data Management

    Job Locations US-MA-Waltham
    Posted Date 1 month ago(10/29/2018 12:43 PM)
    Job ID
    2018-1806
    # of Openings
    1
    Category
    Biometrics - Dept
  • Overview

    The Associate Director, Data Management provides strategic leadership and data expertise to the development teams, with a focus on delivering high quality, reliable clinical trial information to support the execution of clinical programs/protocols across all phases of development. May be responsible for overseeing direct reports accountable for data management deliverables.

    Responsibilities

    As a member of the clinical study or project team(s), provides oversight of the Data Management CROs, ensuring delivery of quality data and documentation on time, on budget and to Radius’s quality standards and Standard Operating Procedures to support corporate goals and objectives.

    • Selects/ manages multiple vendor relationships, resolves disputes and ensures timely acquisition of high quality deliverables, according to internal and regulatory standards. Participates in vendor audits as needed.
    • Acts as central point of contact for data related deliverables, issues, challenges, risks and mitigations for a program(s) or asset(s).
    • Performs review and is accountable for critical CDM study documentation and develops/participates in testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts as applicable.
    • Participates in study document reviews, e.g. clinical study protocols, statistical analysis plans, mock tables, figures and listings (TFL) shells and planned TFL outputs and be accountable from the data management perspective.
    • Develop DM documentation, including SOPs, Work Instructions and/or Guidelines as assigned.
    • Oversees the appropriate and effective use of data management information and system tools for data and report retrieval, data listing review, error detection and production of standard displays to ensure quality data.
    • Contributes to developing strategies for and implementing ongoing improvements within Data Management to ensure the quality and integrity of the clinical data. Collaborates with Biostatistics and Programming to help build the Biometrics function. Identifies opportunities, and implements solutions to globalize and standardize methods, processes, procedures, systems and templates.
    • Represents Clinical Data Management on cross-departmental projects and initiatives and other ad hoc multidisciplinary teams as required, collaborating with Clinical Operations, Clinical Development, Medical Affairs, Pharmacovigilance, Regulatory, Project Management, Clinical Pharmacology, Translational Sciences and Clinical Supplies in support of deliverables and regulatory needs.

    Qualifications

    Requirements:

    • 8 or more years of pharmaceutical industry experience in data management.
    • 3 or more years of pharmaceutical industry experience in oncology.
    • Must have a MS (or above) degree in medical, nursing, pharmacy, biology, biostatistics or related field.
    • Must have thorough knowledge of applicable regulations, ICH guidelines, CDISC requirements and models such as CDASH and SDTM, and clinical/scientific terminology common to biopharmaceutical setting.
    • Must have hands-on experience and expert knowledge of data management practices and data capture methodologies (EDC, IRT, ePRO, etc.) including previous experience managing outsourced data management activities for phase I-IV studies.
    • Familiarity with use of industry standard dictionary thesauri is preferred. Working knowledge of Risk Based Monitoring a plus.
    • Excellent interpersonal skills and problem-solving capabilities, strong project management and mentoring/leadership skills and strong organizational and time management skills with the ability to work independently and coordinate workload in a team environment to meet established deadlines.
    • Experience with supervision of data management personnel in the biopharmaceutical or CRO industry is preferred.
    • Demonstrated ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner.

     

     

    Work Environment:

    The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet.   Frequent travel required.

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

    Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.

    Equal Opportunity Employer Statement:

    Radius Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Radius Health, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

     

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