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Director/ Sr. Director, Clinical Operations
Job ID: 2
Type: Regular Full-Time
# of Openings: 1
Category: Clinical Ops – Dept
- Provide strategic input, management and oversight of clinical development pipeline across all therapeutic areas, managing several phase I/Ib/II and clinical pharmacology studies simultaneously.
- Provide line management, training and mentorship to clinical operations team members.
- CRO and vendor (phase I unit) selection, management and oversight from study start up through study completion. Including management of enrollment, clinical supply and drug supply, data cleaning, and assist with the writing of clinical study report.
- Identifies and/or anticipates clinical study risks and plans accordingly for mitigation and escalates issues to management as necessary.
- Support key data points review to include key efficacy and drug safety data via an Electronic Data Capture system, as needed.
- Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems.
- Facilitation of Clinical Agreements through Clinical and Legal review. Oversee the tracking of trial budgets.
- Contributes to Global clinical / regulatory submissions (FDA, EMA, Canadian and other countries), IRB / EC submissions, review and approval of regulatory packages (as needed), assisting with in house and site inspection readiness planning and training, as needed.
Experience and Qualifications:
- Level of role will be dependent upon the experience of the candidate.
- Requires a BS or equivalent in the health or life sciences is required.
- 3 -5 years of direct clinical study management experience as Clinical Trial Manager or Clinical Project Manager is required, with ability to support multiple phase I/IIb/clinical pharmacology studies simultaneously.
- Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook; Electronic Data Capture Systems).
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.
To Apply: https://www.jobg8.com/ATSApply.aspx?ClHc5OEqhJOKG7t8H5Akkwh