Overview

Radius Health

Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to . Click here to navigate to the EEO is the Law poster. Click here to navigate Radius Health’s Pay Transparency Policy.

AD, Clin Ops Records Management

US-MA-Waltham

Job ID: 2
Type: Regular Full-Time
# of Openings: 1
Category: Clinical Ops – Dept

Responsibilities

Essential Responsibilities:

  • Provide leadership to the records management team fostering a collaborative team culture while ensuring goals and timelines are met with quality, in compliance of SOPs and regulatory guidelines. Identifies and/or anticipates risks and plans accordingly for mitigation and escalates issues to management as necessary.
  • Acts as the clinical operations TMF/eTMF process owner by providing expertise, best practices related to the clinical records management, system implementation and training development.
  • Assist with site/sponsor audits and regulatory inspections, assisting with in-house and site inspection readiness planning and training.
  • Provide mentorship and potential line management responsibilities to clinical operations team members and assisting records management as the department grows. This could potentially include; review of work, resource allocation/time management assessment, training, support and guidance.

Qualifications

Experience and Qualifications:

  • 5-8 years’ experience in a pharmaceutical, biotechnology or clinical research organization (CRO) setting.
  • 3+ years’ experience with trial master file/records management, oversight, maintenance, document review and QC is required.
  • TMF audit and/or regulatory inspection preparation/readiness (site and/or sponsor) and/or related quality/compliance position is preferred.
  • Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required.
  • Excellent computer software skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook; Electronic Data Capture Systems).
  • Requires a BS or equivalent in the health or life sciences is preferred.

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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Tracking

To Apply: https://www.jobg8.com/ATSApply.aspx?e6qBK%2biM1ukTuSI85Jxwdgi