Senior Manager, Clinical Data Management

Salary depends on experience
Posted on 06/21/18
Boston, MA
8 - 10 years experience
Pharmaceuticals & Biotech
Salary depends on experience
Posted on 06/21/18

Job Overview

Data management leadership on a large I global project, or multiple projects with responsibility for the development of the project Data Management Plan; data management systems set-up; and data accession, data entry and data review specifications and processes; and oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project timelines and budgets.

+ Develop and maintain a close liaison with project client contacts, core team members, and Project Managers to drive the data management aspects of project delivery.

Education/Qualifications

+ University/college degree (life science, pharmacy or related

   subject preferred), or certification in a related allied health  p

   profession from an appropriately accredited institution (e.g.,  n

   nursing certification, medical or laboratory technology).

+ Additiona l relevant work experience will be considered in lieu

   of formal qualifications

+  Broad knowledge of drug development process.

+ Thorough knowledge of effective clinical data management

    practices.

+ Thorough knowledge of ICH Guidelines and GCP including

    international regulatory requirements for the conduct of clinical

    development programs , especially as related to data handling

    and processing.

+ Thorough knowledge of time and cost estimate development

   and pricing strategies.

+ Understanding of global clinical development budgets and

   relationship to productivity targets.

Experience

Minimum Required:

+  Minimum seven (7) years relevant work experience in data

    management with four (4) years technical supervisory

    experience to include data management, clinical operations,

    and knowledge of several therapeutic areas.

+  Demonstrated skill for technical and supervisory leadership of

    8-15 staff within one or more locations in a region.

+  Excellent oral and written communicat ion and presentation

    skills.

+  In depth knowledge of clinical trial process and data

    management, clinical operations, biometrics, quality

    management, and systems applications to support operations.

+  In depth knowledge of tracking of staff productivity and quality

    metrics.

+  Demonstrated skill for mentoring and developing staff on

    technical and core competencies.

+  Working knowledge of the relationship and regulatory

    obligation of the CRO industry wit pharmaceutical I

    biotechnological companies.

+  Operational experience in other disciplines such as clinical,

    biometrics, medical writing, pharmacovigilance,  safety, quality

    assurance, regulatory, etc.

+   Demonstrated ability to lead by example teams on strategies

     and achievement of department goals, objectives, and

     initiatives and to encourage team members to seek solutions.

+   Strong leadership and interpersonal skills.

Job Number 2018-20750

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